market access the challenges for niche specialist products

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Page 1: Market access   the challenges for niche specialist products

PARIOFORMA

They are dominating pipelines, and their sales are forecasted to grow at twice the rate of traditional products for the next five years. By 2013, global revenue from specialty products will exceed $160 billion. But with such rapid growth comes unique challenges…

The specialty market place is very different to primary care markets – characterized by a tight KOL universe, small patient numbers, and high barriers to entry (high development cost, intensity of competition, threat of substitution).

In addition, manufacturers of niche specialist products face unique informational and evidentiary demands to demonstrate comparative value.

Of all factors contributing to product success, payer access is considered the most critical – therefore, the sooner Market Access is at the table, the more likely successful pricing and reimbursement strategies are to be realized.

With the high cost of many specialty products the stakes on Market Access are extremely high.

Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom

www.parioforma.com

Globally, over 60% of pharmaceutical industry growth can be attributed to specialty care brands. These are high-priced, specialized, often biopharmaceutical molecules that have limited patient and prescriber populations, high annual treatment costs, and restrictions on access, use, and reimbursement.

SPECIALTY PHARMACEUTICAL

SALES GROWTH, 1999-2008

Page 2: Market access   the challenges for niche specialist products

PARIOFORMA

Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom

www.parioforma.com

Product: For use in advanced metastatic cancer.

Indication: Initial indication 2nd line with potential for future launch in 1st at a higher dose.

Issue: To understand how this may affect payers’ decisions when assessing the product and in negotiations on price. The client wanted to gain payer insights on the future of managing price and access in oncology and how best to support this new product during its review for reimbursement, funding and listing.

Response: The Parioforma team conducted a multi-country review, engaging with payers to: ◦ Establish the relative importance of the uncertainties relating to this

product and their expected impact on pricing and access;

◦ Evaluate the capacity of alternative access programs to mitigate these uncertainties.

Some country insights from this study are highlighted in the chart.

Case Study:

Pre-launch pricing and reimbursement strategy for an oncology product.

Country

Insights

CZ – BI and CE are important and no

experience in developing risk

sharing strategies NL – product

needs to demonstrate that it

provides more "health" than

comparators at a reasonable cost

BE – risk sharing not official but

common practice for all Class 1 drugs

FI – different funding and pricing mechanisms for IV

and oral drugs

PT – price negotiations are based on BI and cost per QALY

PL – cost per patient is

paramount for drugs administered

under special therapeutic

programmes

Page 3: Market access   the challenges for niche specialist products

PARIOFORMA

Every buying system has multiple purchase decision makers, each with different value perceptions and influence.

We have developed a strong network of payers and payer influencers at national, regional and local level across more than 40 markets worldwide.

We can help you understand:

The approval and decision-making environment related to coverage, pricing , and reimbursement on a country-by-country basis (including emerging markets);

General characteristics of healthcare delivery systems including common barriers and recommendations to facilitate market entry;

Best practices for developing an access strategy;

Methods for communicating value propositions to hospitals in individual markets.

With a network of over payer 500 specialists worldwide - our scope is global and we have the resources and experience to tailor our services to meet your needs…

For further information, or to discuss your Market Access requirements, contact us now on +44 (0) 207 225 3538 or email Charles Rowlands at: [email protected]

Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom

www.parioforma.com

Our Services:

We specialise in qualitative & semi-quantitative directional pricing research - from broad payer assessments for early stage assets to detailed country planning and payer engagement for pre-launch and marketed products.