Starting in 2020, Medicare# Advantage plans will be allowed to apply step therapy programmes to the Part B* drugs, a category that comprises drugs that are infused or injected in physician offices and hospital outpatient clinics. Part B drugs include the expensive specialty drugs, including some cancer medications that account for an increasingly large share of pharmaceutical spending. The Centers for Medicare & Medicaid Services (CMS) has been trying to rein in spending on drugs in the six ‘protected classes’, a group that includes antidepressants, antipsychotics, anticonvulsants, immunosuppressants for transplants, antiretrovirals, and, perhaps most importantly – at least as far as cost is concerned – cancer drugs.

In an attempt to reduce spending on these drugs, step therapy has been introduced. This policy, also commonly called ‘fail first’ according to Dr Patt, ‘allows insurers to overrule physicians’ prescribing decisions – forcing patients to begin with the insurer-preferred therapies before advancing to the non-preferred ones’.

Dr Patt argues that step therapy removes her ‘ability to make care decisions – putting that responsibility squarely in the hands of faceless bureaucrats at an insurance company who often have no direct knowledge, training or expertise in cancer care’.

Dr Patt also points out that ‘since CMS began allowing step therapy in Medicare Advantage plans early 2019, [her] oncology practice has seen insurers deny patient access to certain chemotherapy drugs despite physician recommendations’.

The introduction of step therapy would surely be an advantage for less expensive biosimilars. However, although CMS – and commercial plans – claim that step edits reduce costs by giving plans more ability to negotiate with drug manufacturers, Dr Patt says that her oncology practice ‘has seen insurers demand patients fail first on a more-expensive brand drug before they can try a less-expensive biosimilar version’.

She says that ‘this is happening even though the list price is lower for the biosimilar, meaning patients with high deductibles or coinsurance based on the list price would pay less’. This Dr Patt cannot understand, ‘Why would an insurer deny coverage of a cancer drug that has been prescribed by a patient’s oncologist in favour of a more expensive one?’.

Dr Patt therefore concludes that ‘it’s time for Azar and his colleagues at CMS to withdraw this policy and prohibit step therapy practices for Medicare Part B drugs altogether’.

#Medicare is a national social insurance program, administered by the US federal government since 1966. It provides health insurance for Americans aged 65 and older who have worked and paid into the system. It also provides health insurance to younger people with disabilities.

*Medicare Part D, also called the Medicare prescription drug benefit, is an optional US federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs through prescription drug insurance premiums.

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