Treatment Algorithms

May 2009

Treatment Algorithms in Hypertension

Report Authors
Madhuri Borde, Ph.D.

Introduction:

Although early-line treatment in the mature hypertension market is dominated by generics, branded drugs continue to enter and succeed in this market due to the presence of a sizeable patient population which is not at their appropriate blood pressure goal and the subsequent requirement for a multi-faceted treatment approach. This report analyzes U.S. patient-level claims data to uncover which brands have been most successful in penetrating early-line treatment, shifts in the use of antihypertensives as patients progress through lines of therapy, the positioning of angiotensin II receptor antagonists (AIIRAs), such as Novartis’s Diovan (valsartan), Daiichi Sankyo’s Benicar (olmesartan), Merck’s Cozaar (losartan), and Bristol-Myers Squibb/Sanofi-Aventis’s Avapro (irbesartan), as well as Novartis’s renin inhibitor Tekturna (aliskiren) in hypertension treatment, and patient flow to fixed-dose combinations (FDCs) from single agent components versus other drugs. This report couples this analysis with a survey of 151 U.S. cardiologists and PCPs to determine the relative advantages and disadvantages of leading therapies, major factors for moving patients to a new line of treatment from early-line drugs, preferred treatment choices for common comorbid conditions, and how hypertension treatment is likely to change over the next two years with the launch of the first generic AIIRA and AIIRA/diuretic combination (losartan and losartan/hydrochlorothiazide, respectively), thus making it a critical asset for any brand team looking optimize their drug’s positioning within the hypertension market.

Questions Answered in This Report:

  *   Lines of therapy: Although generic angiotensin-converting enzyme (ACE) inhibitors are prescribed first line, their side effects (dry cough in particular) have contributed to the AIIRAs (which also target the renin-angiotensin-aldosterone system) gaining a foothold in early lines of therapy.  How much of early-line patient share is devoted to generic versus branded antihypertensives? What percentages of newly diagnosed patients receive each AIIRA on each line of therapy? What percentage of patients taking each first-line drug move to a second-line therapy within a year?

  *   Pathways to key therapies: Tekturna, Novartis’s Exforge (Diovan/amlodipine), and Daiichi Sankyo’s Azor (Benicar/amlodipine) are among the most recent entrants to the U.S. hypertension market. What percentage of patients moving to each of the FDCs in our analysis received one of the drug’s single-agent components in the previous line of therapy? How are physicians integrating Tekturna into their treatment of hypertension? What do these patterns suggest for emerging Tekturna-containing FDCs? How long do patients stay with their previous drug before moving to an AIIRA, FDC, or Tekturna?

  *   Physician behavior: Our analysis of patient-level claims data suggest that only a minority of the patients moving to an AIIRA as a non-first-line agent come directly from an ACE inhibitor. What clinical or commercial factors prescribe physicians to prescribe Diovan, Cozaar, or Benicar over another AIIRA? Do these drivers differ between surveyed cardiologists and PCPs? To what extent to physicians switch within the AIIRA class, and what do they cite as the leading reasons to change to a new line of treatment?

  *   Forecast: Surveyed physicians eagerly anticipate the launch of the first generic AIIRA, generic formulations of Cozaar in 2010. How will cardiologists and PCPs shift their use of ACE inhibitors and the remaining AIIRAs following the availability of generic losartan? How does physicians’ projections regarding their use of Novartis’s Tekturna/Diovan FDC and Tekturna/amlodipine FDC by line of therapy compare with their projections for Exforge, Azor, and other FDCs? What percentage of the prescriptions for the newer branded beta blockers –GlaxoSmithKline’s Coreg (carvedilol) CR and Forest Laboratories’ Bystolic (nebivilol)—will be in early lines of therapy, broken out by physician segment?

Scope:

Primary research: Quantitative results from our survey of 151 physicians (76 cardiologists and 75 PCPs):

- Physician opinion on how drug use differs by patient severity.

- Most influential drug attributes when physicians choose between agents.

- Anticipated changes in the line of therapy in which physicians use key agents.

Primary patient-level data: Quantitative findings from our analysis of data covering 61 million lives from 98 geographically diverse U.S. health plans:

- Quantified lines of therapy analysis showing exact share of each agent in each line of therapy, including rate of progression between lines and length of time patients are on each line.

- Progression flowcharts through one year of treatment for newly diagnosed patients receiving each of the following first line agents: diuretics, lisinopril, enalapril, ramipril, other ACE inhibitors, atenolol, metoprolol succinate, metoprolol tartrate, amlodipine, diltiazem, nifedipine, lisinopril/HCTZ, benazepril/amlodipine, Diovan, Benicar, Avapro, Cozaar, Diovan HCT, and Benicar HCT.

- Flowcharts tracking the preceding therapy patterns for patients taking each of the following key therapies: lisinopril, enalapril, ramipril, Diovan, Avapro, Cozaar, AstraZeneca’s Atacand (candesartan), Boehringer Ingelheim’s Micardis (telmisartan), Tekturna, Coreg CR, Bystolic, amlodipine, Pfizer’s Inspra (eplerenone), spironolactone, lisinopril/HCTZ, benazepril/amlodipine, Diovan HCT, Exforge, Azor, Tekturna HCT.


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