In early August 2018, the Centers for Medicare and Medicaid Services (CMS) announced it will allow Medicare Advantage plans to implement "step therapy" for drugs covered by Medicare Parts B and D. Under the proposed changes, plans will be permitted to require patients to attempt a less expensive treatment option before they can be prescribed a more expensive one. Medicare Advantage plans administered by private health insurers also could require that a cheaper Part B therapy is used before a more expensive Part B therapy.
The changes were implemented as part of the Trump administration's plan to lower prescription drug prices by offering Medicare an opportunity to negotiate better deals for patients, according to CMS Administrator Seema Verma, MPH. "It may help [Medicare Advantage plans] negotiate better discounts, encourage drugmakers to lower costs, and encourage patients to choose high-value medications," she said.
The new policy would take effect in January 2019, although details are still scarce.
Patient groups, drug manufacturers, and others have expressed skepticism that step therapy would lower drug prices or protect patients' interests. Soon after the decision was announced, more than 90 medical societies, including the American Society of Hematology, co-signed a letter asking CMS to retain a 2012 policy that prohibits these plans from using step therapy.
"[Patients with cancer] should not be forced to â€˜fail first' on a drug that is known not to work for them before they are allowed to take the recommended treatment," said Chris Hansen, president of the American Cancer Society Cancer Action Network, a co-signer of the letter.
Drug manufacturers also voiced their opposition. The Pharmaceutical Research and Manufacturers of America (PhRMA) said it has "serious concerns" with the new policy, arguing that the program would only delay access to needed medicines.
At least one advocacy group, though, supported the changes. "I understand [the concerns] because I have a disease that will kill me if not treated correctly," said David Mitchell, president of Patients for Affordable Drugs. "But if science says drugs are equally effective, I'm okay starting with the cheaper one."
Sources: CMS memo, August 7, 2018; Reuters, August 7, 2018; The Hill, August 9, 2018; Cancer Therapy Advisor, September 12, 2018.