How to Make Rx-Dx Alliances Work - Pharmaceutical Executive


How to Make Rx-Dx Alliances Work
There are big differences between pharma and diagnostic companies-and big rewards for the players who learn to cope with them.

Pharmaceutical Executive

In the pharma realm, physicians decide what drug to select. When it comes to using diagnostic tests in conjunction with a given product, it is equally important for doctors to have the authority to select the brand used. Point-of-care tests give them that control. Physicians prefer rapid tests they can administer in their office rather than those they must send to an independent lab. With such tests there is little risk of delaying a patient's treatment while waiting for results, or worse, having the patient simply not return for treatment. In some disease areas, patients not returning for the results of a test can be as high as 40 percent. Therefore, the greatest opportunity for an integrated Rx Dx promotion lies in brand-name point-of-care tests that yield rapid results marketed with a related therapy.

Time to Market To successfully develop and market a new diagnostic test, both Rx and Dx companies must lay the foundation for the partnership as early in development as possible, preferably at the drug discovery or preclinical stages. (See "Time to Develop," page 54.) However, alliances formed three to four years before the launch of a new drug can sometimes succeed if the test is not too complicated to produce and administer and it gains regulatory approval quickly. However, with such a short timeline, it will still demand considerable sales and marketing effort from both parties.

The use of a diagnostic test during a drug's clinical trials can help validate the test and provide sufficient usage data to support FDA approval. Furthermore, test information is often included in the submission of a new drug application (NDA), giving further credence to the diagnostic's utility.

It generally takes at least two to three years to develop a test and get it to market and considerably more time to prepare the market to accept it. The timeline will be shorter if the new test shows an advantage over others on the market.

Consider a new cholesterol diagnostic test in which benefits might include more accurate results in minutes rather than hours or days. Yet, if the new test offers no significant advantages over others already available, it will typically take at least five to six years from FDA approval to gain market approval.

Rx Dx alliances, by definition, seek to identify new patients for a drug through the use of new diagnostic technologies. Thus, it is important that the partners come up with diagnostic guidelines and standards that will support the new technology. Although pharma companies can and should expect diagnostic partners to lead those efforts, it is important for both companies to work out shared costs in advance of product development.

Make It Mutual Of course, each side must have something the other side needs. (See "Pharma's Stake.") A good relationship between scientists on both sides of a partnership is key to success. "They must be closely aligned and always talking to one another," says one Dx company's director of marketing. Before scientists can work well together, they must have mutual trust in each other's scientific credibility.

Also important is an open dialogue about the need for both parties to look out for their own interests. Failure to recognize that can lead to unfulfilled expectations and, ultimately, disappointment when one partner pulls out of an agreement.

At the outset of a new alliance, companies should ask several additional questions:

  • What attributes does each company offer that will make the partnership a sound fit?
  • How long will the partnership last?
  • Which regulatory pathway must the companies follow to bring the new products to market?
  • Does the pharma company have a clear vision of the disease states with a well defined need for a drug?
  • At what development stage is the drug company's product?
  • Is the patient population clearly defined for clinical trials?
  • Do both the Rx and Dx companies have a good relationship with FDA?
  • What will the price of the test be relative to the price of the drug?
  • Is there already a similar test on the market? If so, will the new test be more effective or more accurate? How will it improve treatment options?
  • Does the Dx partner have strong scientific and developmental abilities with a good reputation and track record for developing tests?
  • Can the Dx company produce the number of tests needed to support the market?

Promoting the Mix A push pull model of diagnostic commercialization illustrates the impact of various forces on market uptake and the overall commercial success of a new diagnostic test. The model includes four potential scenarios:

Dx-only push. Products that receive marketing push from diagnostic companies alone typically take the longest time to achieve a high level of market acceptance-even when there is an added push from large diagnostic companies' sales forces. Market research and benchmark interviews indicate that tests in this category can take up to ten or more years from regulatory approval to reach acceptance in the market. Dx company marketing budgets and sales forces are not large enough to generate the necessary impact on key opinion leaders, clinicians, advocacy groups, managed care organizations, and other payer groups to make new tests widely available and used in a short time-particularly for a new disease marker.

Dx and Rx push. If the marketing and sales push comes from a Dx and Rx co-promotion, but demand from key opinion leaders and advocacy groups is lacking, a new test can often take five to ten years after FDA approval to achieve market acceptance. Without pull from the medical community and consumers, rapid market uptake can require tre-mendous promotional resources from both partners.


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