Pulmonary Arterial Hypertension (PAH): Trends in Treatment

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Pulmonary Arterial Hypertension (PAH):

Trends in Treatment

May 2007

Price $2500

Study Description

Topic	PAH Market
Respondent Type	Physicians
Specialty	Pulmonologists
Region	United States
Methodology	Online survey, self-administered via Panel Intelligence Website Duration: 30 minutes Sample size: 50 respondents Fielding dates: May 7 to May 10, 2007

Study Objectives

To assess the PAH market and expected use of Ambrisentan among pulmonologists

Examine current PAH treatment trends, including monotherapies and combination therapies
Determine anticipated uptake of Ambrisentan, especially with respect to new therapeutic starts
Characterize the expected combination use of Ambrisentan
Evaluate the impact that Ambrisentan’s possible labeling requirements (black box warning, liver monitoring, drug-drug interactions, etc.) will have on prescribing behaviors

Inclusion criteria and Respondent demographics

Inclusion Criteria

Board-certified or eligible pulmonologist
In practice between 2 and 30 years
Spends at least 75% of professional time in clinical practice
Treats at least 10 PAH patients per month

Metric	Mean	Minimum	Maximum
Years in Practice	14 Years	2 Years	29 Years
Percentage of Time in Clinical Practice	94%	75%	100%
Number of Patients Treated per Month	369	100	800
Number of PAH Patients per Month	39	10	350

Key Findings

Untreated PAH: Overall, there is a high proportion of untreated Class I and Class II PAH patients (69% and 45%, respectively). Over the next 12 months, most respondents (74%) expect the proportion of untreated PAH patients to remain unchanged.

Referral Patterns: Pulmonology referrals come most frequently from internists, cardiologists, and general practitioners. The number of patient referrals has increased over the past year, and this trend is expected to continue. The primary reasons for increased referrals are greater awareness and recognition of PAH as a disease.

Current Prescribing: Among first-line therapies for newly diagnosed untreated PAH patients, Revatio® (sildenafil) is most often the first-choice medication for Class II patients. Tracleer® (bosentan) is most often first choice for both Class III and Class IV patients.Among existing patients on treatment, calcium channel blockers (CCBs), Revatio, and Tracleer, are the most frequently prescribed products. CCBs are prescribed more often for Class II patients, Tracleer or Revatio for Class III patients, and Revatio for Class IV patients. Compared with monotherapies, combination therapies are used to a lesser extent. The use of combination therapies has increased over the past 12 months, and this trend is expected to continue due to the availability of newer agents. The use of combination therapy increases with the severity of patient condition (i.e., combinations are used for about one-third of Class III patients and half of Class IV patients).

Emerging Therapies: If both Ambrisentan and Thelin receive FDA approvals, Ambrisentan is expected to have a better uptake than Thelin. Among the endothelin receptor antagonists (ERAs), Tracleer is expected to maintain a slightly greater market share for existing patients; however, Ambrisentan is expected to lead among ERAs in prescriptions for newly diagnosed, untreated patients. If Ambrisentan is approved without the requirement for liver monitoring, its uptake would further increase. It will be more often prescribed for Class III patients than for Class II or IV, especially if liver monitoring is not required (46% vs. 27% and 39%, respectively). Based on the product profiles shown, 82% of physicians indicate they would prescribe Ambrisentan as part of a combination regimen while 60% of physicians would prescribe Thelin in combination. These medications are more likely to be prescribed in combination with Revatio than with other PAH therapies. Most physicians (62%) would prescribe another ERA such as Ambrisentan to Tracleer non-responders but few (12%) would use different ERAs in combination.

Ambrisentan Labeling: Physicians are divided regarding the expectation of a ‘black box warning for liver toxicity for Ambrisentan. The absence of a claim for “reducing the rate of clinical worsening” is not expected to impact most physicians’ likelihood of prescribing. If Ambrisentan is indicated for Class II, Class III, and Class IV patients, and has minimal drug interactions, respondents’ likelihood of prescribing increases. The rates of mild-to-moderate edema associated with Ambrisentan appear to have a minimal impact on respondents’ likelihood to prescribe.

Detailed Findings and Analysis

SECTION ONE: Practice and Referral Patterns

Q1. What percentage of PAH patients in the following categories are NOT treated with drugs indicated for PAH?

Percentage of Class I and Class II PAH patients NOT treated with drugs indicated for PAH:

	Total Responses	Mean	Minimum	Maximum	Standard Deviation
Class I	50	69.46%	10%	100%	25.92
Class II	50	45.26%	0%	100%	30.31

Q2. Over the next 12 months, do you expect the percentage of patients NOT treated with PAH-indicated drugs to:

	n = 50	Increase	Remain the Same	Decrease
Class I	% of Respondents	16%	74%	10%
	Number of Responses	8	37	5
Class II	% of Respondents	26%	54%	20%
	Number of Responses	13	27	10

Percentage increase or decrease for Class I patients, specified

	Total Responses	Mean	Minimum	Maximum	Standard Deviation
Increase by	8	33.13%	10%	100%	27.77
Decrease by	5	21.40%	2%	50%	18.30

Percentage increase or decrease for Class II patients, specified

	Total Responses	Mean	Minimum	Maximum	Standard Deviation
Increase by	13	22.31%	10%	40%	11.84
Decrease by	10	19.7%	2%	80%	23.57

Q2a. To what to do you attribute this change? (Open-ended)

Class I patients – Reasons for change

Responses (Reasons for Increase)		Responses (Reasons for Decrease)
Respondent ID	(n=8)	Respondent ID	(n=5)
3	New medication	2	Availability of sildenafil
11	Efficacy	12	New medications
14	Awareness in diagnosis	20	New drugs
33	Availability of drugs	40	Better medicines
39	Incr. data and awareness of mortality	48	More therapeutic options
41	More choice of oral and inhaled formulations
43	Increased availability of effective drugs that are easily administered, effective, and have fewer side effects
44	More aggressive care

Class II patients – Reasons for change

Responses (Reasons for Increase)		Responses (Reasons for Decrease)
Respondent ID	(n=13)	Respondent ID	(n=10)
3	New medication	2	Ambrisentan and sildenafil
5	More comfort in using drugs	8	Drug options will be increasing
9	More available medicine	12	New medications
11	Efficacy	13

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