16 April 2019

Game-changing RA drugs out of Third World’s reach

APLAR Biologics Medications

Biologic drugs have revolutionised treatment of rheumatoid arthritis, but costs and infection rates mean developing countries cannot take advantage of them, according to APLAR president Syed Atiqul Haq.

The pioneering Bangladeshi rheumatologist, speaking at the APLAR conference in Brisbane, said the costs of bDMARDS put them out of reach for all but a minority of eligible patients in developing countries.

Professor Haq said reducing the costs of drugs was now a global priority, not only one for developing economies, and that costs should be taken into account when developing treatment recommendations.

He noted that biologics were the most profitable drug class in history, and questioned how much above and beyond the value of investment society should pay.

Developing countries tended to have higher out-of-pocket health costs, topped by India, with a mean income of 2000 rupees or $40 [aus] a month, at 50%.

Up to 40% of RA patients in developed countries were prescribed biologic DMARDS, while the global average was only 18%.

Professor Haq said the inhibitory costs of biologics – up to $35,000 [aus] per year per patient in China – could result in flares through early treatment discontinuation and inappropriate dose reduction.

In health economics terms, he said TNF-Is for csDMARD-resistant RA only became cost-effective when the willingness-to-pay threshold was set at [euros]50,000-100,000/QALY. That ruled out the vast majority of developing nations.

Professor Haq said generics and biosimilars had the potential to greatly broaden the availability of treatment and reduce costs by up to 70%.

Then there was the risk of infections, which was already higher in the developing world and increased with the use of bDMARDS, especially TNF-Is. Reactivation of tuberculosis was a particular concern.

Professor Haq said the prescribing of biologics therefore needed to be constrained by using a high threshold, such as Europe’s DAS28>5.1, and should not occur until after eight weeks of an effective dose of subcutaneous methotrexate.

Infections should be vigilantly controlled, with thorough screening, treatment, vaccination and surveillance. And the careful reduction or spacing of doses in patients who had achieved remission or LDA status could keep them disease-free.

He said rheumatologists in developing countries should advocate for changes in government pricing policies; cost reimbursement provisions from insurers, employers and government; and the appropriate use by internists and GPs of csDMARDS.