Presentation content: > Why are some medicines expensive? > Challenges faced by pharma to launch expensive medicines in Indian market > Possible solutions > Summary

1. Challenges Faced by Pharma
to Launch Expensive Medicines
in Indian Market
Dr. Amit Dang
Founder and CEO - MarksMan Healthcare
Communications & KYT - Know Your Treatment
President - ISPOR - Mumbai

2. Contents of the
Presentation
 Why are some medicines expensive?
 Challenges faced by pharma to launch expensive medicines in
Indian market
 Possible solutions
 Summary

3. Why are some
medicines
expensive?
 Drug development is lengthy and
expensive
 Drug discovery, innovation, development,
large-scale manufacture, pre-clinical and
clinical testing
 Low success rate in drug development
 Drug marketing is expensive
 Regulatory approvals in various countries,
intellectual property challenges, drug
marketing related challenges,
‘incentivization’ of physicians for
prescription
 Profitable pharma industry = incentive for
developing new drugs for new diseases

4. Examples for
Expensive
Drugs
 Orphan drugs are often expensive
 Anticancer drugs
 Chronic diseases
 Drugs might be inexpensive, but total cost of therapy is high
 DM, HT, joint diseases, asthma, COPD
 Mental and behavioural disorders
 Cardiovascular diseases

5. Are Drugs
Really
Expensive in
India?
 India is the generic capital of
the world
 Worldwide view: drugs are
cheap in India
 India view: drugs are
expensive in India
 Disparity: because patient is
the payer in India: large OOP
spending

6. Challenges faced by
pharma to launch
expensive medicines in
Indian market

7. Patient Level
Challenges
 Low affordability
 High level of out-of-pocket spending1
 Poor health insurance penetration 1
 Allegations of profiteering by pharma  distrust
 Increasing distrust in practices of corporate hospitals
 Poor adherence to medication  lower sales
1 Dang A, Vallish BN. Indian J Public Health. 2016;60(2):138-141.

8. Regulatory
Level
Challenges
 Achieving patient access of expensive drugs in public hospitals
 Inclusion of drugs in public and private health insurance schemes
 Price capping, NLEM
 Intellectual properties and patent rules in India
 Generic drugs in India
 Counterfeit and fake medicines2,3
2 https://www.bayer.com/en/background-information-on-counterfeit-drugs.aspx
3 Rahman MS et al. Trop Med Int Health. 2018;23(12):1294-1303.

9. Industry Level
Challenges
 Pressure to maximise earning
during early phases of drug life
cycle
 Launch of similar drugs by
other companies: competition
 Need to prove superiority over
existing/ less expensive drugs
for the same indication
 Training and dissemination
 Address criticisms against the
drug
Gronde TV et al. PLoS One. 2017;12(8):e0182613.

10. PossibleSolutions

11. Improve health
insurance
uptake: Role of
HTA
 Insurance can be public (e.g.:Ayushman Bharat) or private
 Launching expensive drugs is easier in insurance-based healthcare
model
 Uninsured: payer will be the patient
 Insured: payer will be the insurance provider
 HTA (health technology assessment) is essential to enhance
insurance-funded model of healthcare payments
 HTA is new in India, but gradually gaining foothold 4
 HealthTechnologyAssessment in India (HTAIn) got established
recently
4 Dang A, Vallish BN. Indian J Public Health. 2016;60(2):138-141.

12. Value Based
Healthcare
(VBH)
 Instead of paying for the drug, inVBH, the payment will be for the
‘Value’ brought by the usage of expensive drugs
 Alternative payment models (APMs):
 Bundled payment model
 Subscription-based: ‘Netflix’ model
 Outcomes based agreements – P4P model
 APMs have the potential to provide justified allotment of payment
for healthcare services, including expensive medicines

13. Patient
support
Programs
 PSPs can improve patient adherence, provide psychological
support, and achieve better outcomes
 PSPs also have potential to improve patient access to expensive
drugs
 Often funded by pharma companies: win-win situation
 Patients get medication access at discounted prices
 Pharma sales are improved
 Need to regulate the PSPs so that there is no mismanagement 5
5 https://www.healthaffairs.org/doi/full/10.1377/hlthaff.28.3.827

14. Miscellaneous
Approaches
 Role of DigitalTherapeutics (DTx)
 Direct to patient advertisements
 Pros and Cons well established 6
 Banned in India: need to relook?
 Charitable hospitals: e.g.,Tata Memorial Hospital, Mumbai
6 Ventola CL.P T. 2011;36(10):669-684.

15. Summary
 Drug prices are high, but are essential to cover up for the expenses
incurred in various phases of drug development
 Various challenges are faced by pharma companies in launching
expensive drugs
 Patient level challenges
 Regulatory challenges
 Industry challenges
 Possible solutions for overcoming these challenges
 Improving health insurance uptake
 Value based healthcare and Alternative payment models
 Patient support programs
 DTx, Charitable hospitals, patient education etc.

16. Thank you!
amit.d@marksmanhealthcare.com and amit@kyt.ai