Money or your life!

Despite the recent South African test case (Erasmus vs Discovery) resulting in the inclusion of biologics as the current treatment algorithm for Rheumatoid Arthritis, this does unfortunately not change the position for a large percentage individuals identified with other forms of arthritis.

As an individual suffering from severe psoriatic arthritis that has evolved to ankylosis spondylitis, with severe debilitation over the years (last 28 years, since the age of 16) resulting in 3 hip replacements to date, my medical scheme has declined the increase of annual limit of biologics, without providing any reason thereto. Off- course the reason is a simple one – simply a financial consideration. The fact remains that medical schemes are run by accountants (financial decision makers) and not medical specialists that would consider the health of an individual or the merit of a

specific case before the financial consideration and possible benefit of such a decision.

Why should a different type of arthritis be excluded as PMB (Prescribed Minimum Benefit), whilst rheumatoid arthritis is deemed to be the only qualifying PMB? For those suffering from severe psoriasis and the debilitating pain and physical deformity linked to ankylosis spondylitis (as example), surely this could not have been a decision based on medical knowledge?

Of the present 1500 SA patients that require anti-rheumatic biologics in the private sector, approximately 800 have RA. The majority of the remaining 47% suffer from Juvenile Idiopathic Arthritis, Ankylosis Spondylitis and/or Psoriatic Arthritis. Why then discriminate in arthritis type as PMB.? Anti-rheumatic biologics can only be prescribed for patients who meet the criteria specified by SARAA. All patients are recorded on an official registry controlled by SARAA, with their numbers therefore being strictly controlled. What case is there for the exclusion of other forms of arthritis as PMB? Surely it is clear that the chances of financial floodgates opening is limited in any event by the prescribed algorithm linked to such a disease – in other words, unless you are deemed physically sufficiently disabled and unless falling within the parameters of Prescribed Minimum Benefit (where leggaly the medical aid is compelled to fund the medication), you WILL be denied or limited in receiving full access to disease modifying biologics!

When a minimal funding per medical scheme member is relevant to biologics medication in South Africa compared to certain other diseases (According to health economist, Professor Tienie Stander in 2006 only R8.7 billion, or 16.9% of total medical scheme contributions in South Africa were paid for medication. This equated to R104 per beneficiary per month, with merely R1.50 per beneficiary per month being for anti-cancer biologics, and 64 cents per beneficiary for anti-rheumatic biologics), it is difficult to understand the measure of résistance to the funding thereof.

The matter remains one of principle – medical schemes pay billions for funding of non-medication expenses, whilst denying full access to medication such as disease modifying biologics that not only beneficially impacts the individual, but also beneficially impacts the contribution of such an individual within society. But then again – an understanding of this can only be developed by being subjected to the disability inherent to arthritis sufferers – a medical decision, not a money decision...

From a personal point of view I will continue pursuing the advocacy of this matter for all types of arthritis to be included as PMB, so as to include biologics as a Disease Modifying Anti-Rheumatic Drug (DMARD) of last resort.

Full funding for arthritis now possible in SA

Full funding of biologic drugs for medical scheme members with severe rheumatoid arthritis (RA) is now a reality.

In a surprising about turn, Discovery recently retracted their second appeal against two earlier rulings by the Council for Medical Schemes, which ordered them to fund their member, Sylvia Erasmus[1], in full for the use of the anti-rheumatic biologic, Enbrel, after previous treatment with a fully funded biologic had failed.

Described by rheumatologists as ‘miracle drugs’, anti-rheumatic biologics have been shown to halt the inflammatory process and to prevent further disease activity and joint damage in RA patients who have not responded to standard drugs and who are literally crippled by the condition. The downside is price, with the cost for anti-rheumatic biologics being in the region of R100,000 per annum.

“The reinstatement of the first appeal ruling in the Erasmus case is significant for RA sufferers because it interprets the current treatment algorithm for RA to include biologics as a Disease Modifying Anti-Rheumatic Drug (DMARD) of last resort,” says attorney Lisa Metzer who represented Erasmus on behalf of The SA Rheumatism & Arthritis Association (SARAA).

“This makes it illegal,” Metzer stresses, “for a medical scheme to levy a co-payment on an anti-rheumatic biologic if it is used by an RA patient after all other standard DMARDs, or fully funded biologics, have failed.” [2]

A further push for full funding of anti TNF agents as PMB drugs of last resort has been given by their inclusion in the third draft of the algorithm for Rheumatoid Arthritis just published in the PMB consultation document on the Council for Medical Schemes website.

This year, Discovery is funding the biologics Revellex, Humira and MabThera in full. They will, however, continue to levy a 10% co-payment on members using Wyeth’s more expensive biologic Enbrel. The reason according to Discovery’s legal advisor, Elton Krawitz, is that “It is not cost-effective at its current price.”

“Unfortunately, there are still many barriers preventing medical scheme members in a critical condition from accessing biologics,” says Mike Boddy, CEO of The Arthritis Foundation. “Generally, they have to be on a comprehensive plan in order to apply for a biologic. Some medical schemes continue to levy co-payments on all biologics making them unaffordable. Many medical schemes also put an annual price limit on biologics. “

“Only 1 500 SA patients require anti-rheumatic biologics in the private sector, “says Dr Beverley Traub, chairman of SARAA. “Of these, approximately 800 have RA. The others have Juvenile Idiopathic Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis.

“Anti-rheumatic biologics can only be prescribed for patients who meet the criteria specified by SARAA. These patients are recorded on an official registry controlled by SARAA, with their numbers therefore being strictly controlled,” stresses Dr Traub.

“Getting medical schemes to fund anti-rheumatic biologics for treatment resistant patients has been a long, tough battle since 2005,” says Arthritis Foundation CEO, Mike Boddy. “However, there are now approximately 95 medical schemes funding biologics as drugs of last resort for members with RA, many without co-payments.

“The central issue with biologics has always been price and the pharmaceutical companies have cooperated since 2006 by dropping or restricting their prices on biologics.”

Putting the price of biologic drugs into context, health economist, Professor Tienie Stander says that in 2006 only R8.7 billion, or 16.9% of total medical scheme contributions in South Africa were paid for medication. This equated to R104 per beneficiary per month, with merely R1.50 per beneficiary per month being for anti-cancer biologics, and 64 cents per beneficiary for anti-rheumatic biologics.

Notes to the editor

[1] Sylvia Erasmus’s Case Study

Now 52, Sylvia Erasmus developed RA at age 27 in multiple joints. She became bed ridden and crippled with many deformities, and subsequently had both knees and an elbow replaced twice in a series of seven operations. She also needed a full time caregiver to bathe, feed and dress her.

Sylvia unfortunately had an allergic reaction to the biologic Revellex (which is fully funded by Discovery), but responded well to Enbrel. She went into remission and was able to walk again and manage all her daily functions and activities unaided.

After Discovery implemented the co-payment for Enbrel, she had to stop biologic treatment as she was unable to work and relied solely on her husband’s income. She relapsed and after two months was in such agony that she had to be admitted for emergency physical and psychiatric treatment.

Her rheumatologist intervened and lodged two appeals with the CMS who ruled in Erasmus’s favour both times. Discovery lodged a second appeal against the first appeal ruling, but withdrew this appeal in February, 2009.

2 The Medical Schemes Act
According to Regulation 15I of the Medical Schemes Act, a medical scheme is obliged to provide an appropriate substitution drug to a patient, without any financial penalty to that beneficiary, when formulary drugs have been ineffective.

Should a patient’s treatment fail on formulary drugs that are fully funded and the beneficiary supplies the necessary evidence to support such a claim, the scheme is obliged to fund an alternative and proven drug in full. Most medical schemes require that members follow their appeals process in these instances.

Anti-rheumatic biologics – a definition

Described by rheumatologists as ‘miracle’ drugs, biologics target individual molecules called cytokines which are involved in the complicated process of inflammation, thereby either halting, or turning off the underlying disease process.

International data on RA patients taking biologics within three to six months of the onset of RA show that 50% went into remission after using biologics for 12 months compared with only 28% of patients on standard drugs.

The impact of co-payments

A co-payment for biologics is unaffordable for most medical members, particularly when they have to pay a few thousand Rands per month for a comprehensive plan in order to be eligible for this benefit.

In May 2007, 17 rheumatologists attending a rheumatology meeting did a dipstick survey on the extent to which co-payments were affecting their patients. (There were 43 practising rheumatologists in SA at the time.)

* Collectively, the 17 rheumatologists present reported that they had 108 patients who had been adversely affected by co-payments, but who were still managing with difficulty to fund their treatment.
* 48 patients had stopped taking biologics because of the co-payment to the detriment of their health.
* The number of patients in a critical condition requiring biologics, but not able to start treatment due to a co-payment, was 73.

CMS rulings on the usage of anti-rheumatic biologics

Four grievances concerning the funding of biologics have been lodged thus far with the CMS against Pro Sano, Resolution Health, Medshield and Discovery. All rulings were made in favour of the members.

In the first three cases, patients had been denied access to biologics by their medical schemes. Referring to Regulation 15(H) of the Medical Schemes Act, the CMS ruled in all three instances that the member was entitled to have access to an alternative and proven drug after all other drugs listed on the treatment algorithm for RA or medical scheme formulary had failed.

The fourth case against Discovery was the first to deal with the issue of co-payments.

Pricing of biologics

Pharmaceutical companies stress that it is difficult to reduce the price of biologics due to the complex manufacturing process required for these genetically engineered drugs. The prices of biologics used for RA on the SA market have nevertheless decreased, or been contained, since 2006.

The price of Revellex was reduced by 17.5% in November, 2006. In addition, a waste management programme was implemented, resulting in additional savings of between 7 and 23% being offered to medical schemes. No price increases have taken place since the introduction of SEP.

According to Schering Plough, the median weight of a South African patient is 75kg. Three vials would be required per treatment costing R14 760. Eight infusions are required in the first year, costing R118 091. This drops to 6.5 infusions in successive years costing R94 940 per year.

Patients have to be hospitalised for three hours for each infusion and this costs between R300 – R500 per visit.

The price of Revellex varies, however, depending on the weight of the patient and whether vial sharing can be used. In the above example, vial sharing would bring the cost of the induction year down to R98 409.

The price of Humira has been R8 511 (incl. VAT) per month since August, 2006. As the drug is administered every second week by injection, the annual cost is R110 643 (incl. VAT).

The price of Enbrel was reduced by 11% in early 2008. However, the price was increased again this year by 13.2% in line with the statutory price increase permitted for drugs in 2009. The average adult would require treatment costing R9 678.94 per month (incl. VAT). Thirteen treatments are needed per annum, adding up to R125 826 (incl. VAT).

Contact nos

Attorney, Lisa Metzer, can be contacted on Cell: 083 692 4791. Email: lisametzer@mweb.co.za

Patient, Sylvia Erasmus, can be contacted on: Tel: (011) 447 0846

Advocacy director of The Arthritis Foundation, Aletta van der Watt, can be contacted on Tel: (021) 852 5530, or Cell: 083 270 4842, Email: aletta@boma.co.za

Mike Boddy, CEO of The Arthritis Foundation of SA. Tel: (021) 425 2344. Cell: 073 205 1349. Email: mike@arthritis.org.za

Dr Beverley Traub now resides in Germany and can be contacted on. Email: beverley.traub@mweb.co.za

Professor Tienie Stander can be contacted on Tel: (011) 655 7191.

News release compiled by Linda Trump of Cat Communications for The Arthritis Foundation of
SA and SARAA. Tel: (011) 485 2406. Cell: 082 341 7128. Email: ltrump@telkomsa.net.

Biologics Don't raise cancer risk in RA Patients

TNF-antagonists, drugs widely used to treat rheumatoid arthritis (RA), don't appear to cause cancer, say Spanish researchers who analyzed data on more than 4,000 RA patients treated with the biologics.

These drugs, which have been used since 1998 and given to more than 600,000 people worldwide, interfere with biologic substances that cause or worsen inflammation in RA patients. But it's been unclear whether blocking TNF (tumor necrosis factor) increases the risk of cancer, according to background information in an American College of Rheumatology (ACR) news release about the study.

Some studies have suggested an association between RA and certain types of cancer, including lung and blood cancers, but the reasons for this increased risk are uncertain.

The data in this new study came from a drug registry called BIOBADASER, established in 2001 for long-term follow up of the safety of biological therapies in RA patients. The 4,529 RA patients treated with TNF-antagonists were compared with RA patients who didn't receive the drugs.
After they adjusted for age, sex, and RA duration/activity, the researchers found that the rate of cancer in the TNF group was very close to that of the non-TNF group (0.92 percent). Based on this, they concluded that TNF use isn't associated with an increased risk of developing cancer.

"Despite foreseen fears, blocking the tumor necrosis factor does not make patients more prone to develop cancer. All on the contrary, blocking the inflammation cascade may help diminish the overall risk of cancer in these patients," Dr. Loreto Carmona, director of the research unit at the Spanish Foundation of Rheumatology, said in the news release.

The study was presented Monday at the ACR annual meeting, in San Francisco.

The U.S. Agency for Healthcare Research and Quality has more about medicines for rheumatoid arthritis.

Arthritis medications reduce the risk of heart attacks and strokes

Patients prescribed drugs to treat rheumatoid arthritis could be at a reduced risk of heart attacks and strokes, according to a study published today in the open access journal Arthritis Research & Therapy.

An international team of researchers led by Antonio Naranjo of the University of Las Palmas de Gran Canaria, Spain, and colleagues in Argentina, Europe, and the USA have analyzed data from the QUEST-RA (Quantitative Patient Questionnaires in Standard Monitoring of Patients with Rheumatoid Arthritis) study. From this study, including 4,363 patients from 48 sites in 15 countries, the team has examined the causes and effects of rheumatoid arthritis, as well as the potential benefits of medications.

Rheumatoid arthritis is a known risk factor for hardening of the arteries and so can lead to stroke and heart attacks occurring in sufferers ten years earlier than in people without the condition. However, earlier studies have shown that treating rheumatoid arthritis with disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate, may reduce this risk. The current research quantifies this risk reduction in thousands of patients in the QUEST-RA study.
Naranjo and colleagues found that risk, when adjusted for age, sex, disease activity, and traditional risk factors such as lack of exercise, smoking, diabetes, and high cholesterol levels, correlated strongly with the use of drugs to treat rheumatoid arthritis.Taking methotrexate – the most widely used DMARD – for just one year for example was found to be associated with an 18% reduction in risk of heart attack and an 11% decrease in risk of stroke, the researchers say.

"Our study provides further support of the influence of both traditional and RA specific risk factors in the development of cardiovascular events, especially heart attack" the researchers conclude, "As assessed by this study, the risk was lower with the prolonged use of methotrexate, sulfasalazine, glucocorticoids, leflunomide and TNF-α blockers."

In an accompanying editorial, Dr Ronald van Vollenhoven of Karolinska Institute, Sweden, reviews the research article. “The possibility that antirheumatic therapy decreases the risk for cardiovascular complications is tantalizing," writes the author. "The current study, while not exactly proving this point, adds a further measure of support to the concept, and suggests that it must now be formally addressed.
###
Notes to Editors:
1. Cardiovascular disease in patients with rheumatoid arthritis. Results from the QUEST-RA study Antonio Naranjo, Tuulikki Sokka, Miguel A Descalzo, Jaime Calvo-Alen, Kim Horslev-Petersen, Reijo K Luukkainen, Bernard Combe, Gerd R Burmester, Joe Devlin, Gianfranco Ferraccioli, Alessia Morelli, Monique Hoekstra, Maria Majdan, Stefan Sadkiewicz, Miguel Belmonte, Ann-Carin Holmqvist, Ernest Choy, Recep Tunc, Aleksander Dimic, Martin Bergman, Sergio Toloza and Theodore Pincus Arthritis Research & Therapy (in press)
During embargo, article available here: http://arthritis-research.com/imedia/3983133971382053_article.pdf?random=955870

After the embargo, article available at journal website: http://arthritis-research.com/
Please name the journal in any story you write. If you are writing for the web, please link to the article. All articles are available free of charge, according to BioMed Central’s open access policy.
Article citation and URL available on request at press@biomedcentral.com on the day of publication
2. Arthritis Research & Therapy is an international, peer-reviewed online and print journal, publishing original research, reviews, commentaries and reports. Studies relate to the rationale and treatment of arthritis, autoimmune disease and diseases of bone and cartilage. The journal is edited by Prof Peter E Lipsky (USA) and Prof Sir Ravinder N Maini (UK) and has an Impact Factor of 3.8.
3. BioMed Central (http://www.biomedcentral.com/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This commitment is based on the view that open access to research is essential to the rapid and efficient communication of science.

Drug switch may benefit arthritis patients

NEW YORK (Reuters Health) - Patients with rheumatoid arthritis who fail to respond to one of the biological drugs will often have a better response to a second drug within the same class, Danish researchers report in the Annals of the Rheumatic Diseases.

"Our data show that patients with rheumatoid arthritis benefit from switching to a second biologic drug," lead investigator Dr. Elisabeth Hjardem told Reuters Health. The order in which the drugs were given did not seem to matter, she added.

Hjardem, of Copenhagen University Hospital, Hvidovre, and colleagues note that about 30 percent of patients treated with drugs within the class of tumor necrosis factor (TNF)-alpha blockers will require a switch because of poor response or adverse events. TNF-alpha is involved in systemic inflammation and regulation of cells in the immune system. Overproduction or dysregulation of TNF-alpha can result in a variety of disorders, such as rheumatoid arthritis.

In their current study, the researchers investigated the effects of drugs designed to block TNF-alpha function. The most common initial drug was infliximab (Remicade), and second-line agents were usually adalimumab (Humira) or etanercept (Enbrel).

To evaluate what impact this might have, the researchers examined a national biological treatment database with 1,021 patients and identified 235 who switched to a second TNF-alpha blocker after the initial drug failed.

The main reason for the switch was lack of efficacy, reported by 109 patients. Adverse events prompted the change in 72 patients. Switchers were more likely to be younger, to have used higher doses of methotrexate and to have a higher level of disease activity. Three months after the switch, the average Disease Activity Score 28 (DAS28) improved by 1.6 points, and the majority had a good or moderate response using European League against Rheumatology (EULAR) guidelines.


Of the patients who changed drugs because of adverse effects, only 15 percent continued to experience adverse effects and the drug remained still effective.

The second drug's effects lasted up to 92 weeks compared with 37 weeks with the first. However, write the investigators, "it was not quite as high as for the non-switching rheumatoid arthritis patients."

The overall improvement "applies both to patients with lack of efficacy and with adverse events," Hjardem said.

The study was nationwide and represented common clinical practice, making these results "applicable to rheumatoid arthritis patients in general," she concluded.

SOURCE: Annals of the Rheumatic Diseases, September 2007.

Cost of Biologics - Who holds the answer?

Biologics, the new ‘wonder-drug’ in the fight against arthritis, offers the hope of partial or complete remission to people with previously incurable systemic arthritis diseases like rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile arthritis.

But there is no getting around the fact that biologics are very expensive, typically costing 20 times more per patient per day than traditional drugs.

A variety of factors go into the high cost of biologics. For starters, development of the complex proteins and antibodies is much more costly than development of the pharmaceutical industry's traditional synthetic organic chemicals.

Because biologics are mostly "large-molecule" drugs and can be produced only within living cells, the complexity and cost of production of biologics is far greater than manufacturing traditional small-molecule drugs in specialty chemical plants.

With little likelihood that most biologics will face early competition from bio-similars that might help push down prices, role players are concerned about the strain increased use of biologics will impose on the healthcare system.

One extra cost of biologics that could be immediately addressed stems from the fact that many are commonly administered via injection or infusion in a doctor's office (or in a clinic / hospital), unlike small-molecule drugs which are generally taken orally.

In the American healthcare market, higher costs for biologics are also attributed to many doctors who administer drugs in their office -- such as oncologists and rheumatologists -- buying biologics and other drugs directly from the manufacturer, then sell them to patients at a significant profit. This situation is not reflected in the South African market – despite this, the cost of the biologics medication remains of an exorbitantly high nature. Why? Surely development costs cannot be the only contributory factor?

What is the profit margin of pharmaceutical companies then in the South African market? The fact remains that the South African market is a fairly insignificant one (compared to the American market where 20% of medical aid costs are accounted for by biologics and where 40% of arthritis sufferers are on biologics). To make the drugs available to a wider spectrum of arthritis sufferers will place an additional burden on the medical aid industry. Where to we start looking for answers then?

Will the price of biologics come down? Although the manufacturing process is lengthy and expensive, no significant reduction in biologics pricing has been forthcoming in the last seven years, despite considerable strengthening of the Rand.

It’s time for all role players to adopt a policy of transparency – for pharmaceutical companies to re-address profit margins could result in a wider market being reached; possibly resulting in a more transparent approach to payment for and availability of these drugs from the Medical Schemes sector. For a better life...

What is Biologics?

Biologics are genetically engineered proteins derived from human genes. They are designed to either inhibit or supplement specific components of the immune system called cytokines. These cytokines play a pivotal role in either fueling or suppressing inflammation (a key component in several forms of arthritis, such as rheumatoid arthritis and psoriatic arthritis).

In recent years, there have been promising advances in treating rheumatoid arthritis -- especially for those people who do not respond to disease-modifying drugs. The most important advance has been the development of a group of drugs called biologic response modifiers or biologics.

What makes these biologics so different from other drugs used to treat rheumatoid arthritis that modify the immune system is that they affect a specific component of the immune system, not the entire immune system. Thus, these medications theoretically have fewer side effects. Enbrel, Humira, and Remicade (Revelex in South Africa) inhibit a cytokine called tumor necrosis factor or TNF. Kineret blocks the cytokine interleukin-1 (or IL-1). Rituxan selectively targets immune cells known as CD20-positive B cells.

Biologics are unique in their action from other drugs because they affect only one aspect of the immune system, while other drugs will change the entire system process. The theory is that the drugs will therefore have far fewer side effects or ill effects than a medication that is broader in its affect.

The battle of profit vs health

Star Editorial (August 06, 2007 Edition 2)

What price the milk of human kindness? That's a question we can ask in the wake of a study that challenges claims by medical aid schemes that highly effective biological drugs are too expensive to provide.

Biologics are target-specific treatments - such as the breast cancer drug Herceptin - that attack particular cells, cannot be manufactured and are grown from living organisms.

The Biologics Working Group (BWG), which falls under the Pharmaceutical Industry Association of South Africa, states that the average real cost of biologics per beneficiary per month is no more than R2,94. The figure is based on an average medical aid contribution of R700.

BWG economic adviser Tienie Stander, an honorary professor at the University of the North West's Pharmacy School, said his findings proved that biologics could "cross frontiers" in providing hope for cancer patients living under a medical death sentence.
He said the drugs could slow down the progression of several forms of cancer and, in some cases, stop the growth completely.

Stander said that, in healthcare, medical schemes act like short-term insurers.

"The argument is flawed to say that biologics are too expensive. That's why I belong to a scheme - it's the principle of insurance."

Stander said his research showed biologics were cost-effective from a medical scheme perspective as well as when viewed from the "productivity gains of a healthy society".

The medical aid industry, however, maintains that the treatments are too expensive.

That doesn't help change the image many people have of the industry as heartless and money-grubbing.

Surely, there aren't that many people needing the treatments? Surely it's better to make a bit less money and offer more people the chance to live?

Tumor necrosis factor (TNF) blockers - Most commonly prescribed in South Africa

These biologic response modifiers block an immune system protein called tumor necrosis factor, which acts as an inflammatory agent in some types of arthritis. By targeting this protein, TNF blockers can help reduce pain, morning stiffness and swollen joints. Some people experience side effects during or shortly after these drugs are injected, including chest pain, dizziness and difficulty breathing, as well as redness, itching and swelling at the injection site. Additional side effects of biologic response modifiers may include abdominal pain, headache, respiratory infections such as tuberculosis, and other infections. These medications also may increase your risk of demyelinating disorders, conditions that damage the protective covering (myelin sheath) that surrounds nerves in your brain and spinal cord.

Enbrel, Humira, and Remicade (Revelex in South Africa) inhibit a cytokine called tumor necrosis factor or TNF. Kineret blocks the cytokine interleukin-1 (or IL-1). Rituxan (Mapthera) selectively targets immune cells known as CD20-positive B cells.

Enbrel (Etanercept)
Enbrel reduces joint inflammation by blocking a cytokine called tumor necrosis factor, or TNF. Enbrel is given by self-injection under the skin once or twice a week. Many people learn to give their own injections or receive them from a family member who has received proper instruction. A kit is available from the manufacturer that makes drawing up the medicine and injecting it easier. Enbrel may cause irritation at the injection site, which is diminished by applying a cold pack to the injection site prior to injection. Enbrel's effect can also weaken the immune system. Although rare, some people have developed serious infections while taking Enbrel. Anyone with a serious infection should stop taking Enbrel and resume it after being advised by a doctor. If you develop an infection, let your doctor know immediately as you need to be monitored closely. Pregnant women should not take Enbrel because the effects on a developing child are unknown.

Humira (Adaluminab)
Humira also blocks the cytokine tumor necrosis factor. The drug is an injection that can be self-administered. It is usually taken once every two weeks. Rare cases of severe allergic reactions and blood cell deficiencies have occurred with Humira. Bruising or bleeding can be a sign of blood cell problems and should be reported to your doctor immediately. In addition, serious infections have been seen in clinical trials when Humira was taken with the rheumatoid arthritis drug Kineret.

Kineret
Kineret reduces joint inflammation by blocking the cytokine interleukin-1. The drug is administered as one injection daily (can be self-injected or given to you by another individual). This is generally not widely used in practice because of low effectiveness rates. Tell your doctor if you develop signs of an infection, such as fever.

Revelex (infliximab)
Like Enbrel and Humira, Revelex reduces inflammation by blocking the cytokine tumor necrosis factor. Revelex is given by intravenous infusion in the doctor's office or hospital. Each infusion takes about two hours. The intravenous treatments are given three times during the first six weeks of therapy, then every eight weeks. Revelex is given with methotrexate for treating RA. As with other biologics, treatments may weaken the body's ability to fight infection. If you have any signs of infection such as a fever over 100 degrees F, sweats or chills, skin rash, or other symptoms that cause concern, contact your doctor right away.

With any treatment, it is important to meet with your doctor regularly so he or she can closely monitor you to detect the development of any side effects and monitor your treatment if necessary. Your doctor may periodically order blood tests or other tests to determine the effectiveness of your treatment and the presence of any side effects.

Rituxan (Mapthera)
Rituxan is approved for patients with moderate-to-severe RA who have not improved with TNF antagonists, such as Enbrel or Remicade. Rituxan is given as two infusions in the vein -- separated by two weeks -- in combination with weekly methotrexate. The most common side effects include infections and reactions while the medicine is given (called infusion reactions). Symptoms of infusion reactions include flu-like illness, fever, chills, nausea, and headache.

Children's Arthritis Trust (CHAT)

Children's Arthritis Trust (CHAT) offers hope to kids crippled by arthritis.

To help treatment resistant children and teenagers in public healthcare who have not responded to the conventional drugs used for treating this crippling and devastating illness, The Arthritis Foundation has launched a special Children's Arthritis Trust called CHAT (Children Have Arthritis Too). The funds raised by this trust are being used to treat these children with biologics, as well as giving them any additional support they may require.

Described as 'miracle drugs' by rheumatologists, biologics will give the small, treatment resistant group of desperate children the chance of partial or full remission from a life of continuous pain and progressive deformity.

"It is a popular misconception that inflammatory arthritis is an old age illness, says Aletta van der Watt, advocacy director for The Arthritis Foundation. Children can be affected from 18 months and up and many children from rural and disadvantaged backgrounds in South Africa sadly miss being diagnosed until the disease is very far advanced and their joints are already deformed.

Although there are no statistics in South Africa on how many children get juvenile arthritis, recent figures from Australia put the incidence far higher than was originally thought - at one in every 250 children.

The first signs and symptoms of juvenile idiopathic arthritis may include limping or a sore wrist, finger or knee.

Although many children have growing pains, these have no relationship to juvenile arthritis, says Dr Gail Faller, a paediatric rheumatologist currently treating fifty children at Chris Hani Baragwanath Hospital in Soweto. Growing pains are a form of musculoskeletal pain that occurs in young children, peaking at four to five years of age. These occur only at night and are usually behind the knee or in the leg. The pain can be relieved by gentle massage and by giving a mild painkiller like Panado. It is self-limiting and does not require any treatment. Pain that occurs during the day is not due to growing pains!

With juvenile arthritis, joints may suddenly swell and remain enlarged. Stiffness in the neck, hips or other joints can also occur. Rashes may suddenly appear and disappear in different areas. High fevers that spike in the evenings and then disappear are characteristic of systemic juvenile arthritis.

The earlier a child with sore or swollen joints is examined, the more positive the outcome of treatment is likely to be, says Dr Faller. If a child complains about a sore joint for more than two weeks, than seek help immediately, she cautions. Unfortunately, many children habituate themselves to constant chronic pain. So when they complain less frequently, parents often make the mistake of thinking they are better.

When children with juvenile arthritis have flares, or do not respond adequately to standard drugs, they experience intense pain and stiffness, and all their daily activities are affected.

According to Dr Faller, They will struggle to turn on a tap, open a jar, get out of bed and put on their shoes. Handwriting is difficult and they become stiff when sitting in class or at a movie. To top it all, they are even teased by their peers, and sometimes their teachers, who accuse them of being lazy, clumsy, slow and uncompetitive.

For treatment resistant children, biologics offer real hope. Developed six years ago, they target individual cytokines or molecules involved in the complicated process of inflammation, either halting, or completely turning off the disease process. The downside is their expense, with annual treatment per child costing up to R80 000 per annum, depending on the child's weight. The cost does, however, drop significantly when the child goes into remission.

Over the course of this year, The Arthritis Foundation will be engaging in talks with the Department of Health to persuade them to make biologics accessible for extreme cases, says van der Watt.

In the meantime, significant funds need to be raised by CHAT in order to help the critically ill children until the State is able to do so.

How you can help a child crippled by arthritis
You can help one of the treatment resistant children in public healthcare to walk and run again by making a donation to CHAT in one of the following ways:

Should you wish to make a donation via a bank deposit or electronic funds transfer, banking details are as follows: The Arthritis Foundation, Standard Bank, Branch code 020909, Account: 070965226. Please mark EFT deposits with the word CHAT.

To make a donation of R30, you can SMS the word CHAT to 42602.

To make a donation of R20, you can SMS the word CHAT to 40902.

Standard treatment for children with juvenile idiopathic arthritis
Although treatment for juvenile idiopathic arthritis depends on the type of arthritis the child has, most children with JIA start out on a NSAID (non-steroidal anti-inflammatory drug) like brufen, or voltaren, used to control both pain and inflammation. Thereafter, they will take a disease modifying drug (DMARD). These include methotrexate (also a commonly used cancer drug), sulfasalazine, hydroxychloroquine (also used in malaria), and cortisone. Regular blood tests will be taken to monitor the side-effects of these drugs.

Cortisone has severe side effects when used in high doses and for prolonged periods. Children may also need injections of cortisone into their joints for local control. In the case of small children, hospital admission is needed for a day as the procedure is done under general anaesthetic.

If a child does not go into remission with disease modifying agents, or becomes dependent on cortisone for the control of the arthritis, then biological drugs such as etanercept (Enbrel), and infliximab (Revelex) become necessary. All children will also be referred for physiotherapy, occupational therapy and a podiatry assessment.

A new support group for parents and caregivers
Another exciting CHAT development is the formation of support groups for parents and caregivers of children and teenagers with juvenile arthritis.

It is often devastating for a family to be confronted with a diagnosis of juvenile arthritis. Many families feel isolated and face the future alone and with fear. This is where a support group can help.

The Johannesburg support group for parents and caregivers was launched on the 6 November 2006 with the assistance of paediatric rheumatologist, Dr Gail Faller. Aiming to offer information, care and support to parents and children with JIA, this group will bring together parents of newly diagnosed children and those who up to now have been going it alone'. Parents will be able to offer and receive support, keep abreast of new developments in the field and support CHAT.

Parents who would like to start or join similar groups in other areas of the country are requested to phone The Arthritis Foundation helpline on Tel: 0861 30 30 30.

To find out more about the Johannesburg support group for parents and caregivers, contact Tel: (011) 726-7498.

RA drug too costly, say SA schemes

There is a revolutionary new arthritis drug on the market, but some South African medical schemes seem unwilling to pay for it.

A ground-breaking new class of drugs, known as biologics, offers the hope of partial or complete remission to people with previously incurable systemic arthritis diseases like rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile arthritis.

However, they are being blocked by a few of the major SA medical schemes, although they are routinely prescribed for both children and adults by the NHS in Britain.

RA a debilitating disease

Affecting approximately 1% of any population group worldwide, rheumatoid arthritis (RA) can manifest in children from as young as two years and up. In adults, the disease usually starts between the ages of 25 – 50, disabling sufferers in the prime of life, causing pain and deformity, and necessitating lifelong treatment, hospitalisations and often joint replacement operations.

Described by rheumatologists as ‘miracle’ drugs, biologics target individual molecules called cytokines which are involved in the complicated process of inflammation. Data on patients taking biologics within three to six months of the onset of the disease showed that 40% went into remission after using biologics for 12 months. Children and adolescents could achieve complete remission if biologics were prescribed within three to six months of disease onset, with biologics not only halting, but completely turning off the disease process.

Biologics routinely prescribed elsewhere

Forty percent of American RA patients are now on biologics. In Sweden, biologics are routinely prescribed as the first line of choice for the early treatment of RA, within three to six months of disease onset. The use of biologics in treatment-resistant cases of RA has become standard recommended practice in developed countries, but South Africa lags far behind with only 300 users at present out of an estimated 450 000 sufferers.

The downside, unfortunately, is price. Biologics are expensive and cost an average of R10 000 per month at the outset of treatment. Discovery funded biologics until late 2005, but is no longer approving new applications for these drugs. Due to an increase in applications for biologics in 2005, they now argue that biologics are not cost-effective at the current price.
Biologics don’t come cheapHowever, “Biologics have been shown to be cost-effective in overseas studies and there is a very limited demand for these drugs in South Africa,” says Dr Ingrid Louw, chairman of the SA Rheumatism and Arthritis Association (SARAA). She points out that biologics can only be prescribed by rheumatologists and according to very strict criteria. “There should be no problem funding them according to the terms outlined by SARAA,” she says.

A-rated biochemist , Prof Jannie Hofmeyr of Stellenbosch University, is a psoriatic arthritis patient who “got my life back” when prescribed biologics. He points out that not every RA sufferer is a suitable candidate for biologics. “Ideally, they should be prescribed to children and adults within three to six months of disease onset and to patients who have not responded to other treatments,” he says. “Another cost-limiting mechanism is the fact that patients are only kept on a biologic if they respond to it,” says Prof Hofmeyr. Furthermore, the cost drops significantly over time in many cases and when children go into complete remission, it is also possible to wean them off biologics entirely.

Where do medical schemes come into the picture?

“Medical schemes that refuse to fund biologics are giving their patients the same choice in medication as that available to indigent patients in the public sector,” says Dr Louw. “However, medications are the most important part of RA treatment. So paying top dollar for a top medical plan does not necessarily give you top medications, and thus the chance of remission or significant relief.”

After the Herceptin debate, Discovery stated that it was in discussion with the Department of Health and a number of medical schemes on the establishment of an independent body to provide guidance to the SA healthcare industry on funding of new healthcare technologies.
“There has been no further public announcement of progress in the formation of this committee, nor has any arthritis patient group been approached for its input,” says Aletta van der Watt, CEO of the Arthritis Foundation.

Getting the price of biologics down

Will the price of biologics come down? Although the manufacturing process is lengthy and expensive, the SA Biologics Support and Advocacy Group (SABIO) points out that for the last six years the price of the drugs has not dropped in South Africa, despite considerable strengthening of the Rand. “Perhaps pharmaceutical companies should consider reducing profits as a humanitarian gesture,” suggests van der Watt.

Dr Louw is somewhat optimistic about the long-term prospects. “The price of biologics is likely to drop in the future due to the great advances in research and at least ten more agents being in various stages of development,” she says.

(Press release from the Arthritis Foundation in South Africa)

People with arthritis - giving voice to your concerns

"The Arthritis Foundation has taken up the challenge to ensure that people with arthritis will no longer be ignored when political or medical decisions are being taken that affect us."

For too long we have merely accepted the word of our doctors, the ruling of our medical aids, or the service we get in the public health facilities, believing that one little lone voice won't achieve much in the face of bureaucracy, politics or high finance.

Those days will soon be over, says the Arthritis Foundation's Aletta van der Watt. Aletta has recently been elected Chairman of a coalition of some 25 health-related NGO's, called PHANGO (Patient Health Alliance of NGO's). This organisation aims to ensure that all patients' viewpoints are represented at policy level in government, in decisionmaking in the public health service and in payment decisions by private Medical Aid Schemes. PHANGO has already had some influence in the Department of Health's draft Health Policy document, having submitted comment and been invited to meet with the committee responsible for the Health Policy. As a result, the patient's viewpoint is now being taken seriously and civil society representatives have been included on the committee.

The Arthritis Foundation has also linked up with the Osteoporosis Foundation, the SA Rheumatism and Arthritis Association of medical personnel and the SA Health Professionals in Rheumatology (nurses, physio- and occupational therapists) to create a body to advocate the interests of arthritis patients in the South African health care system.

Also in the field of advocacy, the Foundation has launched a support group for patients with Rheumatoid Arthritis, Psoriatic Arthritis or Ankylosing Spondylitis who are on - or considering going on to - one of the new class of drugs known as biologics. The group, named SABIO (SA Biologics) aims not only to support its members and to educate others about the effects of the drug, but also to lobby for a more realistic approach to payment for these drugs from the Medical Schemes sector. SABIO also aims to lobby the public health system to, at the very least, provide biologics for children suffering from Juvenile Arthritis.

Hailed by many as a true 'miracle drug,' biologics can restore patients who were totally debilitated by arthritis, back to their normal life. Unfortunately, along with other new medical technologies, biologics are still extremely expensive. SABIO will be lobbying the various drug companies to lower their prices to a more realistic level.

Anyone who is interested in being part of any of these three advocacy groups and thereby helping us to make your voice heard, please contact Aletta on 021425 2344, Cell 083 270 48 42, email aletta@boma.co.za or aletta@arthritis.org.za.