MEDI-CAL PLACES FIVE ACE INHIBITORS ON PRIOR APPROVAL LIST -- ACCUPRIL, CAPOTEN, MONOPRIL, PRINIVIL AND ZESTRIL; NSAID CATEGORY REVIEW ALSO COMPLETED

Five ACE inhibitor products will be available to Medi-Cal patients only with prior approval of the state agency, following Medi-Cal's "therapeutic category" review of angiotensin-converting enzyme inhibitors: Warner-Lambert's Accupril (quinapril); Bristol- Myers Squibb's Capoten (captopril) and Monopril (fosinopril); and two co-marketed lisinopril products, Merck's Prinivil and Zeneca's Zestril.

All five previously had been listed on Medi-Cal's formulary and available without prior authorization. ACE inhibitors are the third category for which the California Medicaid agency has sought to restrict the number of covered single-source outpatient products in selected categories, based on a combination of price and therapeutic considerations. Medi-Cal had solicited revised price offers from the manufacturers of the delisted products.

Hoechst-Roussel's Altace (ramipril), Ciba-Geigy's Lotensin (benazepril), and Merck's Vasotec (enalapril) remain on formulary following the Medi-Cal review. Medi-Cal spends about $36.8 mil. annually on ACE inhibitors. As a result of the review, the state estimates one-year savings of $4.3 mil.

The review also leaves the state with no combination ACE inhibitor/diuretic products available without prior authorization. The state decided to remove Bristol-Myers Squibb's Capozide and Merck's Vasoretic from the formulary and not to add Prinizide or Zestoretic. The combo products are low-volume items for Medi-Cal, and the state's drug contracting advisory committee is described as believing that the products contain high-dose diuretics that in many cases may not be an appropriate starting dose.

Medi-Cal also recently completed a review of nonsteroidal anti-inflammatory drug products and decided to make only one change.

The state deleted from the formulary sodium salicylate, which accounts for only about 100 scripts per year. Nonetheless, the state projects that it will reduce its $68.5 mil. annual expenditures on NSAIDs by about $5.5 mil. as a result of the review -- suggesting that some manufacturers already on the formulary offered additional discounts to stay there.

Remaining on formulary are Syntex' Naprosyn (naproxen); Wyeth- Ayerst's Orudis (ketoprofen); Upjohn's Ansaid (flurbiprofen); and Ciba-Geigy's Voltaren (diclofenac). Products that were reviewed but kept on prior authorization are Wyeth-Ayerst's Lodine (etolodac); Syntex' Toradol (ketorolac); SmithKline Beecham's Relafen (nabumetone); and Searle's Daypro (oxaprozin).

The changes for the ACE inhibitor and NSAID categories will be implemented July 1, as will those for ulcer drugs. Following an earlier review, the state deleted Glaxo's Zantac and Lilly's Axid from the formulary, leaving SB's Tagamet and Merck's Pepcid on the list ("The Pink Sheet" Jan. 11, p. 3).

Adding the estimated $3 mil. in savings from the ulcer drug category to those for ACE inhibitors and NSAIDs, the state appears to be more than half way toward its statutory savings requirement for the therapeutics category review initiative. In a budget rescue package enacted last year, the California state legislature directed Medi-Cal to find at least $18 mil. in savings from the review. The same package also instructed Medi-Cal to seek across- the-board "supplemental" rebates from drug manufacturers (see following story).

The next categories on Medi-Cal's agenda are beta blockers, calcium channel blockers and antlipidemics. Sometime later, the state will take up antibiotics for review.