Enabling Personalized Medicine Markets | Diaceutics

Enabling Personalized Medicine Markets


This case study demonstrates how diagnostic strategies can significantly improve the return on investment of a therapy outside of drug response testing. It will help you understand:
  • Three strategies that are worth considering to improve ROI
  • Differentiating the therapy
  • Preparing the market
  • Reducing the impact of adverse events
Download this case study to learn more.

1: Case Summary

This case will help you understand:

How diagnostic strategies can significantly improve the return on investment (ROI) of a therapy outside of drug response testing.

Three strategies that are worth considering to improve ROI:

  • Differentiating the therapy
  • Preparing the market
  • Reducing the impact of adverse events
Key messages:

Personalized medicine is newsworthy and also helps to create new competitive dynamics between established therapies.

Successful personalized medicine campaigns always have a simple message and an understandable clinical rationale.

A successful personalized medicine strategy is best executed when it is an integrated part of the therapy's overall launch and promotion.

Personalized medicine can help manage adverse events and restore a therapy's clinical utility.
Key actions:

Plan a Dx strategy and focus on how to improve ROI.

Define your Dx campaign and messages to reach your target audiences.

2: The JUPITER Trial

JUPITER Trial
Trial Chairman: Paul M Ridker, MD

The JUPITER Trial (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) was a multicenter, randomized, double-blind, placebo-controlled 4-year trial funded by AstraZeneca to assess whether rosuvastatin (20 mg daily) can prevent major cardiovascular events among nearly 18,000 healthy men aged 55 and older and women aged 65 and older with normal levels of low-density lipoprotein (LDL) cholesterol but elevated levels of C-reactive protein, a marker of chronic low-level inflammation. The trial was stopped ahead of schedule in 2008 because of a statistically extreme 44% reduction in risk for a first major cardiovascular event among the group of participants assigned torosuvastatin.

So What?

JUPITER was a personalized medicine trial using a high-sensitivity CRP test to isolate patient groups at high risk of heart disease.

Its publication enabled AstraZeneca's Crestor to achieve 35 per cent annual growth.

Commentary

JUPITER is one of a handful of Phase 3/4 clinical trials which has focused on the use of an indirect biomarker to identify a group of patients on whom substantial clinical benefit is realised. The size of the trial and the fact that it was stopped early added to its market impact.

3: Publication of the JUPITER Trial Changed the Rules for Crestor

US
  • Only branded statin to gain share
  • US TRx +25%*
    • ~4 times statin market
  • Only branded statin to gain share
    • Crestor TRx share 10.8% June
  • Dynamic share >15%
    • Second only to simvastatin
RoW
  • Growth 3 to 4 times statin market
  • Western Europe +23%
  • Canada +32%
  • Australia +76%
  • Japan +68%
So What?

Publication of the JUPITER Study in 2008 made personalized medicine newsworthy. A public profile can help create new competitive dynamics between established therapies.

Commentary

JUPITER's findings led to a spike in news flow for Crestor. As one Morgan Stanley analyst put it at the time:

"Jupiter will increase sales of Crestor because it shows the drug is effective, adds a halo effect regarding its safety and eventually, gives AstraZeneca's sales reps something to talk about in the doctor's office. It will also probably make for some nice direct-to-consumer ads, and may give Crestor an edge over Vytorin from Merck and Schering-Plough, which has not been shown to prevent heart attacks or strokes."

Traditionally, a drug like Crestor could have been expected to secure a market share of around 10 per cent but in the 12 months following publication of the JUPITER results, Crestor sales grew by 35 per cent, compared with a 35 per cent decline in Lipitor sales.The use of high-sensitivity CRP testing to ring fence patients for whom Crestor would work best, also allowed for double-digit growth, even several years after launch.

Crestor also benefitted from adverse events associated with a rival drug, Baycol, which led some payers, including Wellpoint, to give Crestor third-tier, non-preferred status in 2006. This was also partly thanks to the availability of high-sensitivity CRP testing.

This US success was emulated in other markets around the world, including Australia and Europe. Crestor also achieved 68 per cent growth in Japan.

4: Leveraging Personalized Medicine to Shape a Therapy's Negative Predictive Value

Merck Establishes New, Non-Profit Bone Measurement Institute
WEST POINT, Pa., Aug. 1995 PRNewswire


Today Merck & Co. Inc. announced it is establishing a new, non-profit organization call the Bone Measurement Institute. “The Bone Measurement Institute will conduct activities to help increase the availability of bone measurement technologies, increase their accessibility to physicians and reduce the cost of bone mass measurement to health care payers.” Said Jeremy Allen, Vice President Merck U.S Human Health, and President of the Institute. It also will provide educational support to physicians about the role of bone measurements and promote scientific research and development of bone testing methodologies.

So What?

A personalized medicine strategy created the bisphosphonates market.

Commentary

The second of the three strategies we will look at is that of preparing the therapy market.

Fosamax was launched in 1995 initially for the treatment of osteoporosis in menopausal women, a market which was small and ill-defined and therefore likely to lead to slow Fosamax prescribing.

Merck decided to complement its market development program with the parallel development of a companion diagnostic strategy.

In the years leading up to the approval and launch of Fosamax, Merck developed strong strategic alliances with manufacturers of bone densitometers, including Hologic and Lunar, which was later acquired by GE Healthcare.

These alliances promoted the distribution of bone densitometer scanners, giving providers broad access to osteoporosis diagnostics. As awareness of the condition increased, doctors could easily have their at-risk patients tested, so creating a market for Fosamax.

5: Biologics Benefit from Diagnostic Targeting

So What?

Successful personalized medicine campaigns always have a simple message and an understandable clinical rationale. The injunction to "Know Your T-score" is key to defining a patient's bone density and treatment options.

Commentary

Merck worked with experts in osteoporosis to turn the complicated X-ray data and analysis into simple results. The "T-score" it came up with meant that the decision on whether or not to use Fosamax was clear for doctors and their patients.

To maximize the propensity-to-prescribe (or P2P, the ratio of therapies applied to positive tests) for a therapy dependent on a test result, the reporting of the result must be as simple as possible. Ideally it should be, "Yes, prescribe," or "No, not eligible."

6: Personalized Medicine Worked for Merck

  1. The National Osteoporosis Foundation (NOF) was established in 1986 to educate patients and the general public about the prevention of osteoporosis
  2. Fosamax qd
  3. Merck established the Bone Measurement Institute to promote the use of BMD tests
  4. Merck funded the largest study in osteoporosis, the National Osteoporosis Risk Assessment (NORA), reaffirming the need for prevention
  5. Fosamax in men
  6. Merck DTC campaign
So What?

A successful personalized medicine strategy is best executed when it is an integrated part of a therapy's overall launch and promotion.

Merck used such a strategy and paved the way for Fosamax to become a billion-dollar drug.

Commentary

As the first significant drug in the class, Fosamax was expected to take a major market share. Typically, first drugs in their class secure around 40 per cent market share.

However, the market-shaping and lifecycle strategy pursued by Merck, enabled by its investment in diagnosis and, in particular, the establishment of institutes to promote bone density testing, delivered superior market rewards despite the entry of several competitors.

Other key elements in the strategy included improved dosing options and an indication for men as well as women. Merck was also building on foundations it had laid in 1986 when it funded the National Osteoporosis Foundation to educate the general public about osteoporosis prevention.

7: The Abacavir Case

So What?

GSK used the abacavir example with investors to illustrate its personalized medicine strategy.

8: Abacivir Hypersensitivity Reaction

So What?

Abacavir hypersensitivity significantly impacted GSK’s sales and resulted in a prescription ratio of only 1 to every 4 prescriptions of its nearest competitor drug, Truvada from Gilead.

Commentary

Half of GSK’s HIV portfolio consisted of drugs containing abacavir (ABC). In 2003 it was found that 5 to 8 per cent of treated patients were suffering from a drug-specific hypersensitivity which manifested itself in flu-like symptoms. This led to the FDA placing a 'black box warning' on the labels of all ABC-containing drugs and a consequent plateau in sales.

9: Epzicom

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So What?

One person treating HIV clearly described the impact:

“In the past, we always had to expose a patient to a drug to see if there is a reaction. This, to the best of my knowledge, is the first example where we can predict an allergic response without having to expose the patient."

Commentary

Prior to launching the test program Epzicom was trending towards a sales plateau around $80m each quarter. The launch of the testing program quickly impacted quarterly drug sales, adding a cumulative revenue to drug sales of $30m within nine months.

The abacavir story continues to be discussed at conferences as an example of how to execute a well-planned personalized healthcare strategy for the benefit of patient and investor. The MAT sales trajectory for Epzicom, one of GSK’s ABC-containing drugs, illustrates the impact this broad market education and test availability had on GSK's quarterly revenue.

10: The Brighton Study

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So What?

Personalized medicine can help manage adverse events and restore a therapy's clinical utility.

Commentary

GSK were able to identify an association between an HLA biomarker and patients who suffered hypersensitivity.

GSK collaborated in a number of retrospective and prospective studies to illustrate the potential role of screening HIV patients before they received treatment with drugs containing abacavir (ABC).

They presented clinical data which illustrated that the use of HLA biomarker-screening prior to patients taking ABC-containing drugs helped eliminate the hypersensitivity issue. Luckily the test for HLA B5701 was already available through LabCorp and Quest, the two largest US laboratories.

This data, together with an extensive education and HLA B5701 testing strategy, was launched in August 2007. It aimed to promote hypersensitivity testing for all new HIV patients immediately after diagnosis, because at some point they were likely to be offered HIV treatments containing abacavir.

11: Key Messages

Key messages:

Personalized medicine is newsworthy and also helps create new competitive dynamics between established therapies.

Successful personalized medicine campaigns always have a simple message and an understandable clinical rationale.

A successful personalized medicine strategy is best executed when it is an integrated part of a therapy's overall launch and promotion.

Personalized medicine can help manage adverse events and restore a therapy's clinical utility.
Key actions:

Plan for a Dx strategy and focus on how to improve ROI.

Define your Dx campaign and messages to reach your target audiences.

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