Harbingers of Change - Pharmaceutical Executive

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Harbingers of Change
What to watch—and watch out for—in the bottom half of '07


Pharmaceutical Executive


The Harbinger In June 2006, Britain's National Institute for Health and Clinical Excellence (NICE) issued new guidance that beta-blockers should not be used routinely as an initial therapy for high blood pressure. NICE recommended that all new patients be prescribed an angiotensin-converting enzyme (ACE) inhibitor, a calcium channel blocker, or a diuretic. The rationale was that newer drugs, while slightly more expensive, offer a better efficacy/risk balance over the long term. At the time of the decision, approximately two million Brits were already taking beta-blockers.

Also in 2006, the German Agency for Health Technology Assessment (DAHTA) decided that insulin analogs should no longer be reimbursable for new patients unless the price was cut to match those of human insulin. The agency determined that "there is no convincing evidence of the superiority of rapid-acting insulin analogs compared to regular insulin in diabetes mellitus type 2 therapy."

The Change Health-technology assessment (HTA) is becoming important in key illness areas where evidence exists to support change. In Britain, the impact of NICE's guidance was apparent within three months. Prescriptions for beta-blockers as first-line therapy for patients under 55 fell by 50 percent, while scripts for ACE inhibitors grew by 30 percent. Meanwhile, promotion of ACE inhibitors declined by 27 percent. In the 55-and-over population, prescriptions for calcium channel blockers as an initial treatment rose from 17 to 27 percent over the five months following publication of the guidelines. Again, promotional spending on calcium channel blockers fell.

In Germany, as soon as DAHTA announced its decision in April, physicians began turning to regular insulin more often for new patients. By October, a month after the reimbursement change went into effect, 80 percent of all new patients in the therapeutic class were prescribed regular insulin. Physicians began switching patients from insulin analogs to regular insulin a month before the reimbursement change.

The Implications The British situation suggests that HTAs can transform the way patients are managed—even without restrictions on reimbursement.

But how will physicians respond if an HTA issues guidance on a well-managed patient population? If physicians are as responsive in such a case, manufacturers will need to put more emphasis on their loyalty programs and not assume that a managed population is safe from product switching.

These two decisions also suggest that mandated changes to treatment regimens (protocol by fiat) may become the norm. So far, assessors have demonstrated that they endorse the concept of progress and are taking a long view of economic value and therapeutic effectiveness. Pharma companies should view HTA entities not solely as cost-saving bodies focused on the value of market access, but also as agents for changing long-held medical practices. The NICE and DAHTA decisions are likely to raise eyebrows in other countries, causing other HTAs to reexamine their own evidence for potential agreement.

Clearly, manufacturers must continue to invest in evidence-based research to support their health economics and outcomes claims. In particular, it will behoove companies to target their therapies and to submit evidence to HTAs on that basis, given that it is easier to prove superior value in a select subgroup of patients than among all disease sufferers. Investing in health economics may, in the long run, save money in the promotional budget.

The IMS Health editorial board includes: Murray Aitken, senior vice president, corporate strategy; Diana Conmy, corporate director, market insights; Thomas Foster, vice president, client thought leadership; Simon Holt, vice president, IMS consulting; Graham Lewis, vice president, global pharma strategy; John MacCarthy, vice president, client thought leadership; Ana Maria Zaugg, chief marketing officer. IMS Health's Intelligence.360 is available for download at http://www.imshealth.com/.


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Harbingers of Change
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