I am curious if there is any drug price control (DPC) or
simply price dictatorship policy being done in our neighbors in the ASEAN and
developed Asia. A friend showed me a copy of the latest quarterly report of
IQVIA, formerly IMS Health. It is a by-subscription paper only. It’s cool. I checked
two categories in the report and I chose 10 economies (this picture from drugs.com).
The country
abbreviations are as follows:
PH – Philippines; ID – Indonesia; TH – Thailand; VN –
Viet Nam; MY – Malaysia;
SG – Singapore; JP – Japan; KR – S. Korea; TW – Taiwan;
HK – Hong Kong.
IQVIA MARKET
PROGNOSIS 2020-2024 Key Findings
Published March 2020
Drugs Pricing
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Pharmaceutical
Business Environment
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PH
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* EO 104 (Feb. 17, 2020) has MWP, MRP for 87 molecules
or 133 drug formulas. Plus additional 35 molecules.
* Mandatory 20% price discounts for senior citizens,
PWDs. To be extended to cancer patients, spouses of OFWs, single parents.
* Manufacturers say they have been hit hard by VAT
exemptions and introduction of 20% discounts on medicines for senior
citizens.
* After diabetes, high cholesterol, and hypertension,
the next tranche of VAT-exemptions planned to be applied on drugs targeting
cancer, psychiatric disorders, tuberculosis and kidney diseases, expected to
come into effect from 2023 onwards.
|
* Some companies may withdraw some drugs, or withdraw
completely from the market. Price cuts could drive reduction up to 1/3 in
pharma jobs.
* Previous withdrawal of some multinationals (Eli Lilly
and Bristol-Myers Squibb)
* Attractive market for foreign generic houses.
* Lack of skilled labor, high utility costs.
* Generics-only pharmacies will continue to flourish.
Pharmacy and drugstore chains will further expand, small, independent players
to become marginal.
* Pharmacies to witness demand spike in first part of
2020 due to panic purchases of cough and cold remedies, immune supplements,
anti-infectives etc.
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ID
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* Explicit regulatory price controls remain unlikely,
tools designed to limit the price of products on the FORNAS will remain in
place
JKN funding issues, HTAs, competition for e-catalogue
tenders and private hospital cost containment efforts will all ensure that
pressure on drug prices remains intense.
* Private hospitals now have access to e-catalogue bid
prices, demand for discounts.
* Regulators to attach other factors like quality and
supply capabilities, which would rule out submission of bids by small,
low-quality manufacturers.
* Margins on JKN business will remain thin while demand
for larger discounts in the private sector will pose further threat to
manufacturer profits.
|
* Virus to negatively impact local pharma manufacturers
given their heavy reliance on imported raw materials from China. Lengthy
disruption to manufacturers’ supply could add upward pressure on prices
particularly generics.
* Outbreak to boost demand for OTC medicines. Vitamins,
antibacterial gels, cough and cold meds.
* Few multinationals will invest significantly unless the operating climate improves. Regional
generics and biosimilar players are more likely investors but will have to
operate through joint ventures with local partners unless existing caps on
foreign investment are relaxed.
* More consolidation in the distribution sector where
falling prices, payment delays and rising compliance costs will further squeeze
margins.
|
TH
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* Median pricing of National List of Essential Meds (NLEM)
and some non-NLEM drugs will remain a key cost-containment policy in the
public sector’s three healthcare schemes.
* Manufacturers enacting strategies to mitigate impacts
of median pricing like promoting product
differentiation to compete with generics, forging partnerships with
government bodies or local suppliers, investing in R&D, outsourcing sales
and marketing activities.
* Competition among manufacturers to supply government
hospitals will remain intense, with ministerial regulations under the
Procurement Act favoring GPO and products on the Thai innovation list.
|
* Surge in air pollution in 2019-2020 to see surge in demand
for-and-uptake of OTC medicines for respiratory and skin ailments, vitamin C
supplements. Exacerbated by COVID-19
outbreak as a result of the anticipated shift in patient behavior.
* Greater innovation in pharmaceutical sector, formation of the Ministry of Higher
Education, Science, Research and Innovation in May 2019. More conducive
environment for R&D through clinical research roadmap (2018-2022),
expanding the Thai innovation list, and speeding up the launch of and access
to innovative medicines.
* Government Pharmaceutical Organization (GPO) will
continue as supplier of generic medicines to government hospitals.
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VN
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* Drug prices under growing pressure as efforts to curb
SHI reimbursement costs are stepped up.
* MOH to pursue consolidated tendering for more drugs.
Logistical issues will limit near-term increases in the use of national
tenders, however, leaving provincial tenders as the dominant mechanism for
levering down prices in the public sector.
* Procurement prices for 139 off patent originator
(OPO) products will be subject to negotiations, with negotiated prices coming
into effect from early 2020.
|
* Further development of local manufacturing will be
encouraged but regulatory compliance costs will lead to exit of some small
domestic players.
* Demand for generics will continue to rise, driven by
public sector procurement strategies, SHI reimbursement policies and further
gradual increase in SHI coverage.
* Imposition of tighter quality standards will improve
physician and patient attitudes to generics but regulatory compliance costs
will trigger a degree of consolidation in the generics market. Biosimilars
and cheaper ‘biocopies’ will gain some traction.
|
MY
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* MOH announced in May 2019 that external reference
pricing will be used to benchmark against cheaper medicine prices in eight
other countries, with a ceiling price being set based on the average of the
three lowest prices identified.
* Timeline of implementation and reference countries
considered are uncertain.
* Information sharing by the MOH, Ministry of Defense
(MOD) and Ministry of Education (MOE)
will place them in stronger negotiating position with manufacturers.
* Government plans to implement price controls at wholesale
and retail level. No specific proposals have yet been publicized.
|
* Malaysian companies increasingly looking to the
export market as a new revenue stream over the past 12 months. They face the
challenge of increasing volumes to generate economies of scale to compete
with Indian manufacturers on price.
* Innovative drug sector – dominated by foreign
companies – still accounts for a sizeable value share of pharmaceutical
market, faced with a number of headwinds over the next few years. These
include a large patent cliff, greater drug price regulation, and competition
for tenders in the public sector.
* Future growth may be curtailed by the price controls
that the government is planning to impose at the retail level.
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SG
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* Pricing pressure in public sector will remain strong
as subsidy list expands.
* Downward prices intensified by government’s
bulk-purchasing practices.
* Medicine prices in private sector will face less
pressure than in public settings, with regular market dynamics remaining the
main factor affecting price in the near-term at least. Major private hospital
groups began to establish centralized purchasing agreements for some
therapies.
|
* Multinational drugmakers are well established in
Singapore and continue to expand their manufacturing output via new
production plants and upgrading existing facilities.
* Retail pharmacists are set to take on a larger role
in the primary care setting, relieving the burden on doctors and helping to
reduce repeat general practitioner (GP) consultations. The separation of
prescribing and dispensing functions remains a distant prospect.
|
JP
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* According to MHLW, the April 2020 biennial NHI price
revision will see price cuts averaging 4.38%, whilst any price rises will not
be permitted to exceed prices set in the one-off price revision of October
2019.
* More than a dozen high-cost therapies will undergo
considerably larger price cuts on the basis of their high sales values,
including leading product Keytruda (pembrolizumab).
* Revision to methodology for setting prices of new
medicines will see more innovative medicines that are not PMP-eligible
undergo price cuts four years after their initial listing.
|
* Japan’s pricing environment progressively eroding
prospects for innovative medicines.
* Industry unlikely to withdraw investment in developing
and commercializing new products in the near term, but global launch
strategies could place Japan lower down the priority list in the longer term.
* COVID-19 impact on pharma manufacturing since China
is a key global source of APIs.
* Sales force retained by many pharmaceutical companies
is declining. Research-based companies are refocusing on specialty medicines,
which require more targeted promotional activity.
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KR
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*Ministry of Health and Welfare (MOHW) committed to expand patient access to
medicines for rare diseases (such as cancer).
* These will be in addition to actual transaction price
(ATP) cuts imposed every two years; ATP cuts in January 2020 averaged
1.96%.
* Risk-sharing agreements (RSA) to become more
prevalent to secure reimbursement subsidies for high-cost medicines.
* Changes to generic pricing system will be phased in
from July 2020. Generic products currently priced at 59.5% of the originator
price in the 12 months following patent expiry, falling to 53.55% after one
year.
|
* Domestic companies are diversifying business
interests beyond generics. Leading players are investing in R&D
activities and upgrading manufacturing facilities to boost export trade
* Environment for multinational companies is perceived
as somewhat hostile. The market is considered to offer sufficient growth
potential to remain attractive, but pricing pressures will mean careful
consideration of launch strategies to avoid damaging prices in key markets
such as China.
* Sales and marketing activities being held to
increasingly higher standards as a result of legislative changes and
industry-imposed standards.
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TW
|
* Price volume agreements (PVAs) will remain one of the
main tools to limit the budget impact of expensive new drugs. PVAs limit the
amount a company can earn, they have the advantage of enabling new drugs to
obtain reimbursement listing more quickly.
* Companies with a Managed Entry Agreement (MEA) likely
to need to sign PVA.
* First MEAs were implemented in 2019 for three
immuno-oncology products. MEAs are one way for a new product's price to be
screened from international comparisons.
|
* Stricter regulatory standards resulted in some
consolidation in the domestic industry over the past few years; low prices at
home have increased the importance of export markets, especially for new
products seeking better price.
* Growth in imports is outpacing that of exports and
imports account for much of the Taiwanese market.
* Strong growth in biomedicine start-ups, helped by
extensive government support. First new drugs from Taiwanese companies being
launched worldwide.
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HK
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* Tendering and negotiations are central to drug
pricing. Benchmarking with competitors is the norm, although prices remain
free from explicit regulatory control. Institutional market prices will
continue to be controlled indirectly by tender-based procurement and the
significance of HADF listings, while health maintenance organizations (HMOs)
and private providers will adopt more aggressive approaches to purchasing in
a bid to lever prices down.
|
* Private sector growth will be fueled in part by
immediate post-launch demand for new drugs from Chinese patients, although
this has begun to moderate as China’s drug launch lag narrows to three months
from prior 1-2 years.
* Enhance R&D capabilities of public hospitals
through an earmarked sum of HK$17 million in fiscal 2020 budget. Government set
aside HK$1.2 billion to fund Hong Kong Genome Project implementation through 2025
to deliver improvements in cancer and rare disorders treatment.
|
So of the 10 economies reviewed here, only the
Philippines has new DPC policy. And this EO 104 (February 2020) is on top of
price control under EO 821 (July 2009) which remains in effect until today.
Malaysia plans to have DPC both at the wholesale and
retail levels, but no details yet when, how many molecules and so on.
Some good alternatives to drug price dictatorship are as
follows:
1. Indonesia’s HTA, competition in e-catalogue tenders, private
hospitals’ access to e-catalogue bids.
2. Thailand’s stiff competition among manufacturers to
supply government hospitals.
3. Vietnam’s negotiated pricing for off patent originator
(OPO) products.
4. Malaysia’s information sharing by different
Ministries/agencies.
5. Singapore’s government bulk-purchasing practices.
6. Japan’s high sales values and volume, bulk purchase.
7. Korea’s Risk-sharing agreements (RSA) to reimburse
subsidies for high-cost medicines.
8. Taiwan’s Price volume agreements (PVAs) with
manufacturers.
9. Hong Kong’s Tendering and price negotiations. And
10. Philippines’ own Generics law, new off-patent medicines
become available to local generics firms for cheaper mass production.
The important thing is that innovators should be
encouraged to bring their new, patented drugs to the country. Let them come and
compete among each other. We should not scare and demonize them with price
dictatorship and even patent confiscation via compulsory licensing. Later the
local generics firms will join the competition.
----------------See also:
Drug Price Control 44, News stories in 2019 on DPC, March 19, 2020
Drug Price Control 45, News stories in early 2020 on DPC, March 28, 2020.
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