Mass. Medicaid Holds Line Against GSK Line Extensions

Prior authorization will be required by Massachusetts' Medicaid program for two GlaxoSmithKline antidepressant line extensions.

GSK's Wellbutrin XL (bupropion) and Paxil CR (paroxetine) now require prior authorization, under Dec. 1 changes in the ¹ MassHealth Drug List.

The state is requiring prior authorization because the two line extensions provide only a marginal benefit over their predecessor drugs, the agency said.

Furthermore, the Medicaid program intends to convert Wellbutrin patients to generic bupropion.

Eon Labs' ANDA for extended-release bupropion 100 mg cleared FDA Nov. 25. Launch of the generic may hinder GSK's efforts to convert Wellbutrin SR patients to XL (² (Also see "Eon Wellbutrin SR Generic Launch Could Slow GSK Conversion Efforts" - Pink Sheet, 1 Dec, 2003.), p. 17).

However, Eon's launch has been delayed by two restraining orders (see ³ (Also see "Eon Wellbutrin SR Generic Launch Delayed By Two Restraining Orders" - Pink Sheet, 8 Dec, 2003.) ).

Paxil CR will require prior authorization until a more substantial clinical benefit over Paxil is observed, Massachusetts Medicaid said.

In addition, use of Paxil in patients under 18 years of age now requires prior authorization. The state said this requirement was prompted by an FDA notice cautioning against pediatric Paxil use to treat major depressive disorder due to a possible increased risk of suicidality (⁴ (Also see "GSK Paxil Pediatric Safety Concerns Have No Effect On Adult Use, FDA Says" - Pink Sheet, 23 Jun, 2003.), p. 6).

FDA's concerns about suicide potential related to antidepressants have expanded beyond Paxil. The agency recently said further data analysis and discussion on antidepressant use in pediatrics is needed (⁵ (Also see "FDA Expands Pediatric Suicidality Caution To Antidepressants Beyond Paxil" - Pink Sheet, 3 Nov, 2003.), p. 11).

The prior authorization requirement is expected to increase physician awareness of FDA's caution, Massachusetts Medicaid said.

Other changes to the state formulary include the addition of AstraZeneca's statin Crestor without a prior authorization requirement (see ⁶ (Also see "Crestor Impact Review To Precede Mass. Medicaid Preferred Statin Decision" - Pink Sheet, 8 Dec, 2003.) ).