Statin Penetration In U.S. Is Example Of Benefit Of Rx Promotion - BCG Study

The relatively high use of HMG-CoA reductase inhibitors to treat cholesterol in the U.S. is an example of the more rapid penetration of innovative drug classes in less controlled markets, a Boston Consulting Group study maintains.

In the U.S., about 90% of cholesterol treatment involves "statin" class agents, according to IMS Health data cited in the report. In international markets with more government controls on pricing and promotions, statin use is lower, the report suggests.

While some countries, like France and Japan, have similar per capita rates of statin use as the U.S. (9-10 days of therapy per capita), the newer class represents a much smaller proportion of total cholesterol drug consumption in those countries, BCG found. Other countries, like Germany, Spain, the U.K. and Italy, have a relatively high proportion of statin use, but a lower overall rate of cholesterol treatment (about 5-7 days of therapy per capita) than in the U.S.

Moreover, "the cross-country comparison indicates that the U.S. has experienced the fastest growth in usage; most of the growth represents growth of the entire drug category, and only a small part is driven by switching," the report states. From 1992-1997, per capita use of statins increased by about four days in the U.S., with less than half-a-day of the increase coming from switches from older therapies, the BCG analysis found.

The time period of the analysis may have influenced the finding: following the expiration of Warner-Lambert's patent for Lopid on Jan. 4, 1993, the HMG-CoA reductase inhibitor class has been the only aggressively promoted cholesterol-lowering class in the U.S.

To support the argument that increased use of statins should be encouraged, the report cites a 1998 American Journal of Cardiology study suggesting that "nearly 12% of the adult U.S. population would benefit from drug therapy that lowers cholesterol levels," as well as cost-effectiveness data from studies of Bristol-Myers Squibb's Pravachol (pravastatin) suggesting that use of statins lowers the cost per life year saved from $200,000 with diet and exercise alone to $40,000-$45,000.

The BCG report, "Ensuring Cost-Effective Access to Innovative Pharmaceuticals: Do Market Interventions Work?" commissioned by Warner-Lambert, was unveiled April 29 at a press conference in Washington, D.C.

The report is likely to be cited frequently by the pharmaceutical industry as the Medicare debate unfolds to counter proposals that involve price controls. The contents of the report were previewed by Pharmaceutical Research & Manufacturers of America President Alan Holmer during the association's annual meeting in March ("The Pink Sheet" April 5, p. 27).

BCG's analysis of the adoption of new drug classes specifically addresses one of the industry's vulnerabilities in the current political debate.

Industry critics frequently cite pharmaceutical promotions and especially the recent surge in direct-to-consumer advertising as a factor in inappropriate use of high-priced products. In addition, critics view the promotional budgets as a potential cushion for companies to absorb cuts in prices for their products.

Restrictions on promotion, whether direct (bans on DTC advertising in most countries) or indirect (price controls that reduce the payback from aggressive promotion), can have a "negative impact" for "patients suffering from classically undertreated conditions," the BCG report maintains.

"Increasing treatment rates for these kinds of diseases crucially depends on building awareness among physicians and in the population at large," the study points out.

In addition to analyzing the statin class, the report examines selective serotonin reuptake inhibitor antidepressants and proton pump inhibitor anti-ulcerants.

The global usage pattern for SSRIs is similar to that for statins, the report indicates. Newer antidepressants are used more frequently than tricyclics and "atypicals" in the U.S. relative to the six comparator countries.

However, the report acknowledges, the case for encouraging SSRI use is less "clear cut" than for statins. "Although the data on the relative pharmacoeconomic cost-effectiveness of SSRIs versus tricyclics are equivocal, the consensus is increasingly that SSRIs should be prescribed as first-line therapy because they have lower discontinuation rates and are more likely to be prescribed at appropriate doses," the report maintains.

The report reveals that the U.S. has been relatively slow in adopting proton pump inhibitor ulcer therapies compared to countries like the U.K., Spain, France and Italy.

"In the case of anti-ulcerants, proton pump inhibitors in many markets have a clear cost-effectiveness advantage in the treatment of gastro-esophageal reflux disease but a less clear advantage in the treatment of peptic ulcers," the report states.

"In U.S. practice, on-patent proton pump inhibitors are relatively much more expensive than off-patent H2 antagonists or older anti-ulcerants such as bismuth. As a result, the cost-effectiveness argument for proton pump inhibitors as first-line therapy is generally weaker, and the new drugs have not penetrated as fast," the report says.

"It is worth noting that marketing spending in and of itself is not enough to drive consumption of a drug that offers little, if any benefit," the report asserts. BCG analyzed IMS data to determine the "relative marketing effectiveness" (defined as treatment days per dollar of marketing) for the SSRIs in the U.S. BCG concluded that marketing effectiveness declined for each successive entrant in the market.

Marketing alone does not drive uptake of innovative drugs, the report acknowledges. "Clearly, intercountry differences in medical practice play some part in the patterns of treatment," the report says, citing France and Japan as countries with especially high rates of pharmaceutical consumption.

Another factor may be "the source of a given innovation," the report adds. "As a rule, local manufacturers win a greater share of their home markets than of global markets." Both statins and SSRIs were developed by U.S. companies, while PPIs were developed by non-U.S. firms.

The BCG report includes an analysis of the products that drove the 11% increase in pharmaceutical spending in the U.S. during 1997.

According to BCG's analysis of IMS Health data, more than half of the increase was due to 23 products, "many of which are part of a new generation of treatments for chronic diseases. Any assessment of the costs incurred in providing these drugs must be balanced with an analysis of their benefits," the report says.

The statin class, where Warner-Lambert launched Lipitor, accounted for $1.1 bil. of the $5.1 bil. increase in Rx spending, according to the BCG analysis. Antidepressants (Lilly's Prozac, SB's Paxil, Pfizer's Zoloft and Glaxo's Wellbutrin) accounted for $700 mil. Warner-Lambert recently launched the newest SSRI antidepressant, Celexa, under a copromotion agreement with Forest.

Diabetes medications, including Warner-Lambert's Rezulin and Bristol-Myers Squibb's Glucophage, accounted for $600 mil. of the increase. Lilly's antipsychotic Zyprexa alone accounted for $500 mil., while Glaxo's migraine therapy Imitrex accounted for $200 mil. The antihistamines Claritin (Schering-Plough) and Zyrtec (Pfizer) added another $500 mil.

The main focus of the report is amassing data to support the brand name industry's argument that price controls are ineffective (and counterproductive) in holding down overall health care spending.

The report also provides data to support PhRMA's oft-stated argument that price controls will lead to reduced R&D spending. BCG sites a leveling off in R&D investments in Germany following the adoption of reference pricing in contrast to a surge in investments in Canada following restrictions and then repeal of the country's compulsory licensing policy.

Another argument made by the BCG report is that price controls discourage generic penetration. An optimal mix of on- and off-patent products in the marketplace allows "headroom" for innovation, the report suggests.

"Eliminating the distortions created by market interventions would lead to greater competition in the generic (multisource, off-patent) market, lowering off-patent prices and shifting consumption from on-patent products to effective off-patent generic substitutes," the report says.

"By taking advantage of the headroom in the current drug budget, governments might then in turn be able to relax controls on the prices of innovative pharmaceuticals."

The generic industry has picked up on the BCG study in its efforts to lobby against proposed patent extension proposals in Congress (see following story).