Medicare Plans’ Preferential Coverage For Off-Label Drugs Debated

A debate is brewing over how Medicare should handle plans' step-therapy practices that encourage beneficiaries to try an off-label treatment before coverage is granted for a drug with an FDA-approved indication.

The treatment of fibromyalgia is one area where the practice is raising red flags; however the policy at stake is not limited to that market.

In fibromyalgia, at issue are requirements by Part D plans that beneficiaries try and fail generics, such as gabapentin, tri-cyclic antidepressants or serotonin re-uptake inhibitors, before coverage is granted for Pfizer's Lyrica (pregabalin) or Lilly's Cymbalta (duloxetine), which are approved for the indication.

New language in the CMS draft call letter to Part D plan sponsors for the 2010 benefit year has led to concerns that the agency wants to curtail coverage practices that steer members to less expensive, off-label treatments through formulary edits. A final version of the call letter is scheduled to be released March 30.

Don't Undercut P&T Decisions, PCMA says

The Pharmaceutical Care Management Association expressed that position in recent comments on the call letter (¹ (Also see "Part D Formulary Edits: CMS Focus On Covering All Labeled Uses Unwarranted, PCMA Says" - Pink Sheet, 10 Mar, 2009.)).

"The off-label use may be as medically appropriate as the indicated use," PCMA stated. Neither the law nor CMS regulations make a distinction between on-label and off-label uses for determining a medically-accepted indication, the group asserted.

"We believe that this distinction inappropriately limits the ability of the [Pharmacy and Therapeutics] committee to exercise its judgment."

The draft call letter states that "in the absence of widely used treatment guidelines or clinical literature, Part D sponsors will not be permitted to require an enrollee to try and fail drugs supported only by an off-label indication (an indication supported only by statutory compendia) before providing access to a drug supported by an FDA approved indication."

CMS said its concerns with step therapy practices have arisen from its review of formulary submissions from Part D contractors.

An agency spokesman elaborated: "When CMS reviews step therapy criteria, the first step drug must have an on-statutory compendia indication. CMS would not allow a Part D sponsor to require a second-line therapy before [a beneficiary gets] first line therapy."

Nevertheless, physicians, patient groups and a number of state attorneys general are seeking a more specific prohibition against the practice, which they say inappropriately infringes on the physicians' discretion in prescribing and "force" use of off-label drugs.

Groups including the Alliance for Patient Access, American Chronic Pain Association and the Oregon Rheumatology Alliance have taken that position.

Some request that CMS remove its reference to "widely used treatment guidelines or clinical literature" and simply bar the practice.

Closing A Loophole

That approach was endorsed in a March 6 letter signed by 16 state attorneys general. The group asserts that by including the qualification, CMS creates a "loophole that threatens to undermine the entire [policy] revision."

Written by Oklahoma Attorney General Drew Edmondson, the letter notes that insurers already rely on treatment guidelines or clinical literature, though it describes such evidence as "often of dubious validity."

"Thus, allowing health insurance companies to continue this inappropriate practice if they can find clinical literature or guidelines to support it will not address the problem."

Another approach recommended in the comments was that CMS set out clear standards on what constitutes credible and widely used treatment guidelines, as well as minimum criteria for acceptable clinical literature.

- Cathy Kelly ([email protected])