MERCK’s PROSCAR REQUIRES SIX-MONTH TRIAL TREATMENT PERIOD TO DETERMINE INDIVIDUAL RESPONSE; FREE SUPPLIES OFFERED THROUGH PATIENT SUPPORT PROGRAM
Merck's Proscar (finasteride) will require a six-month minimum treatment period -- costing the patient about $260 -- to determine whether the therapy is effective, the labeling of the newly- approved 5-alpha-reductase inhibitor indicates. Cleared by FDA on June 19 for "the treatment of symptomatic benign [prostatic] hyperplasia" ("The Pink Sheet" June 22, p. 4), Proscar carries several specific label statements on the length of preliminary treatment required to show efficacy. In the dosage and administration section, for example, the labeling notes that "although early improvement may be seen, at least 6-12 months of therapy with Proscar may be necessary in some patients to assess whether a beneficial response has been achieved." Labeling adds that "periodic follow-up evaluations should be performed to determine whether a clinical response has occurred." The indications section observes that "less than 50% of patients experience an increase in urinary flow and improvement in symptoms of BPH" after 12 months of treatment with Proscar. "It is not possible to identify prospectively those patients who will respond" to Proscar treatment, the label notes. Merck uses the general estimate that 50% of men over 50 experience BPH to describe the potential size of the patient population for Proscar. The company says that decreased urine flow may be experienced by "about 10 mil. men in the U.S. over age 50." Decreased urine flow is often a symptom of BPH. The extended initial treatment period described in labeling appears to cut two ways. It warns the physician and patient of the delayed onset of symptomatic relief associated with finasteride, but it also encourages a long trial-period of treatment prior to a decision on the appropriateness of continued chronic therapy. With safety concerns apparently minimal, the major factors in the decision to start Proscar therapy will be the degree of symptoms and the cost of the trial-period therapy. In an apparent effort to minimize cost concerns, Merck is establishing a coupon give-away program for the first month of therapy as part of an extended Patient Support Program. The company is providing physicians with certificates to give to their patients for a free initial 30-day supply of the drug. If therapy is successful after the first six months and a doctor decides to keep a patient on Proscar, a second certificate for another 30-day supply is available to the patient. Subsequent one-month certificates will be made available "every 12 months until at least 1995," the company said. It is expected that patients who benefit from Proscar therapy will remain on the drug for life. * The direct-to-pharmacy cost of Proscar will be $1.40 per daily of one tablet, contributing to a first-year cost (direct-to- pharmacy) of $427 with the two free months. Merck estimates the retail price at $1.75 per day and $638.75 per year. Subtracting the 30-day complimentary supplies, patients would pay about $534 for the first year of therapy, saving approximately $100. In subsequent years, patients would pay about $586 for Proscar while the starting price and support program last. Citing Merck's commitment to holding down drug prices, the company claims that the price of Proscar "is really well in line with the prices that have been established with other products where there is significant value to the patients." Although Merck highlighted its Patient Support Program in announcements following the approval of Proscar, the company declined to provide details about the distribution of certificates to physicians and patients or the redemption and verification of the coupons by pharmacists. Merck will not be the first pharmaceutical company to try this type of promotion campaign. In 1990, SmithKline Beecham pitted Tagamet against Glaxo's Zantac, offering discount coupons to customers of Thrift Drug's mail-order business. At about the same time, Marion Merrell Dow enrolled patients using Cardizem in its Cardizem Medication Plus Program. The program offered patients a voucher for a free introductory 21-tablet supply of Cardizem and free 90-tablet supplies following cumulative purchases of 540 tablets ("The Pink Sheet" March 5, 1990, T&G-9). Both MMD and SB utilized the SamplePlus Program designed by Medical Marketing Group, a subsidiary of Medco Cost Containment ("The Pink Sheet" April 8, 1991, T&G-12). Merck would not comment whether the certificates were being developed in-house or being contracted to an outside firm. * The Patient Support Program potentially could open a new window of opportunity for Merck. Although the company did not confirm how the certificates would be distributed, it seems likely that with the exception of the first round, certificates will be sent directly to patients, and therefore the company would be able to obtain important mailing information for Proscar patients. Merck potentially could acquire medical information about Proscar customers, thereby accruing a significant database of male patients over 50 -- a population marked by high pharmaceutical usage. Merck explained that under the support program, "patients will also receive periodic health information, including a newsletter." Using this type of direct-to-consumer information campaign, Merck could conceivably establish a strong company-patient relationship. Ties between the company and patients could have long-term benefits, such as creating a deterrent for generic use and generating interest in other Merck products. Using a coupon program as an alternative to heavy free sampling also should appeal to pharmacists, who generally lose some sales revenues under give-away programs. Proscar will be available in pharmacies "by the end of July," the company said during a June 22 press conference, "and it may be available in some pharmacies sooner." Educating physicians about the Patient Support Program will be a focal point of Merck's promotional campaign for the drug. The firm plans to use sales representatives and medical journal ads to achieve this goal. * During the press conference, Merck Executive Director of Clinical Research Elizabeth Stoner, MD, emphasized the clean safety profile of Proscar. According to labeling, adverse reactions to the drug "usually have been mild and transient." The only adverse experiences reported in greater than 1% of patients treated for 12 months were sexually related, labeling states, and included impotence, decreased libido and decreased volume of ejaculate. Just over 1% of the 453 patients cited in labeling were discontinued from treatment due to the drug therapy. The recommended dose for Proscar isn 5 mg once a day. Labeling warns that women who are or may become pregnant should avoid absorbing finasteride "through either direct contact with crushed Proscar tablets or from the semen of a patient taking Proscar" because of the potential risk to a male fetus. In addition to Phase IV trials to study long-term safety and efficacy of Proscar, Merck has committed to several other studies for the drug. According to the company, the contract for a trial determining the efficacy of Proscar in concomitant use with Abbott's alpha blocker Hytrin (terazosin) is still pending legal review within the Department of Veterans' Affairs. Recruitment for a study of Proscar's effect on balding should begin sometime "within the next month" the company said. During the press conference, Merck Sharp & Dohme Research Labs President Edward Scolnick, MD, noted the speed with which Proscar was approved. Commenting on the 14-month approval period, Scolnick said that Merck "had to work very hard to keep up with the pace thrust upon us by the FDA." The timing of the Proscar approval is significant in light of the upcoming guidelines on BPH that will be issued by HHS' Agency for Health Care Policy and Research. AHCPR says the guidelines, which were originally slated for a June-July publication, now should be available in autumn. Developers of the guidelines will consider including information on Proscar, AHCPR said.
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