Pain Management Marketplace Marketing Excellence Plan

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Information about Pain Management Marketplace Marketing Excellence Plan
Business & Mgmt

Published on February 13, 2014

Author: aharrell2000



This slide presentation is for illustration purposes only and to show how AH2 & Beyond Consulting can help you build your Global Marketing Excellence Strategy Plan.

Pain Management Marketplace A “Global Marketing Excellence” Strategy Presentation By Andre’ Harrell

This slide presentation is for illustration purposes only and to show how AH2 & Beyond Consulting can help you build your Global Marketing Excellence Strategy Plan All content & data is fictitious and is only for illustration purposes

Below are objectives you can utilize to set up your strategy Objectives • • • • • • • • • Market Analysis Competitive Analysis Buying Process Customer Analysis – Segmentation Value Proposition Positioning SWOT Critical Success Factors Strategic Priorities

Understanding the regulatory process/requirements are critical at the beginning build of your marketing excellence plan Regulatory Key Events (2014) US and EU Jan US Feb Mar Apr May Jun Submit RMP Proposal to FDA Jul Oct Nov Dec // 2015 FDA RMP mtg =Key regulatory milestones =Corporate regulatory submissions (base case) =Target regulatory approvals/license Aug Sep NDA Resubmission Target: NDA Approval June 15

Acute Pain Market Overview Establishing a Market Overview in your plan sets up a strategy of “Where To Play”. The next few slides examine a therapeutic class within the healthcare sector as an example.

A Shifting Perspective on Pain • The impact of pain is evident on many levels – Social • Special Congressional mandate declared 2000–2010 as Decade of Pain Control and Research to generate increased understanding and awareness of pain – Clinical • Pain is now considered the 5th vital sign • Elevated awareness of pain and its clinical sequelae – Regulatory • JCAHO guidelines recognize that patients have a right to appropriate assessment and management of pain • Growing RMP requirement • National Patient Safety Goals – Other • Anesthesiologists no longer reimbursed for post-op pain management • Growing movement toward outpatient surgery

Surgical Trends Inpatient • Complexity of inpatient surgeries growing – Neurologic procedures (craniotomies) – Transplants – Bone repair/microsurgery • Inpatient surgical costs scrutinized for most hospitals – Hospitals focusing on improving clinical efficiencies to maximize cost recovery • Increase in minimally invasive surgery Outpatient • Increasing transition to outpatient surgeries (OP) – Hysterectomy (either ambulatory or 23-hour) – Shoulder surgery – Cholecystectomy • The ability to transition surgeries to OP highly dependent upon pain management – 30% of all readmissions based on pain issues – Inability to tolerate orals after anesthesia

Inpatient Acute Pain Landscape 54M+ Inpatient Procedures and Diagnoses 38M Unique Inpatients 18M Opioid Requiring Patients 14M Patients Requiring “Injectable” Opioid 5.8M inpatient surgical procedures 1.8M other surgical procedures [within key specialties] [outside key specialties] • Orthopedic • Cardiovascular • OBGYN • Neurological • General 6.8M inpatient non surgical procedures and diagnoses “Non-Surgical Acute Pain” • Vascular(Micro) • Urology Segments included in revenue forecast Source: Solucient LLC AC Tracker data, HCUP data

Acute Pain Primary Stakeholders • Anesthesiology (32,113) • Anesthesiologists Role – Responsible for the post anesthesia care unit (PACU) – Order all epidurals and some IV PCA – Key influencers in surgeons decision of post op pain plan – Often lead acute pain teams • Surgeons – – – – – Orthopedic (24,231) OB/GYN* (42,912) General (31,822) Urology* (11,106) Other (27,292) • Surgeons Role – Acute pain management not primary focus – Order most of the IV PCA, all IM, all orals • Secondary Targets include: Pharmacists, PACU Nurses, Floor Nurses

Ambulatory Surgery Center Insights • • • • ASC’s conduct both surgeries and diagnostic procedures There are about 3,000 Ambulatory Surgery Centers (ASC) Primary specialties involved in ASC’s are GI, Opth, GYN There is some IV opioid use in recovery; low levels of PCA mostly for ORS procedures • Pharmaceutical spend is low, roughly $25/case • Reimbursement at ASC’s is typically lower than in hospitals

Competitive Landscape Establishing a Competitive Landscape in your plan can help you set up a strategy of “Offense”, in addition, gather an understanding of your products strengths & weaknesses

IV PCA Overview WHY ACCEPTED • Patient in control of pain management • Lower opioid consumption • Removes delay in analgesic delivery / gaps • Can be customized for each patient – Flexibility (opioids, dose, duration, basal, etc.) • Nursing preference – No repeated needle sticks – Reduce time requirements for staff & patients DOWNSIDES • Invasive (IV access required) • Potential for programming errors • Need qualified personnel to administer • Involves multiple departments in hospital to coordinate and deliver care

IV PCA Trends • Addressing IV PCA Safety Issues – Smart pump technology becoming more prevalent • Bar-coding to minimize errors • Pre-filled syringes for multiple opioids • Wireless communication with hospital IM system

Product X • Company: • Indication: • Price: $161-191 for 48 hours • Forecast: $25-30M (net in 2014) • Sales Force: 150 Hospital Sales Reps • Clinical Data: 876 patients (Hip & knee replacement, Lower Ab, C-Section) • Advantages: Single shot, no need for indwelling catheter, reduce/eliminate PCA • Disadvantages: Invasive, long lasting, supplemental analgesic requirements • Initial feedback: Administration issues with Product X Product Pharmaceuticals/Skye Intended for single dose administration by the epidural route for the treatment of pain following major surgery. Administration is prior to surgery.

Acute Pain Market - Conclusions • Broad audience with differing needs • Several factors effect post-op analgesic selection • Multiple modalities used based upon patient and surgical processes • IV PCA is cornerstone of post-op pain management – highly rated based on patient control, flexibility, and efficacy – drawbacks based upon invasiveness, administration error, complexities (logistical) • Increasing scrutiny of IV PCA safety issues • Current pump advancements focused on safety features • Continual monitoring of Product X impact

The “Buying Cycle” Understanding the “Buying Process” for any product establishes the buying patterns of your customer in addition to understanding the various buying personalities of your top customers. Many marketing plans do not have a “Buying Process” which separates our template from many.

The Buying Process (Example) Physician submits P&T request (Avg 4 weeks) Sub-committee Agenda & Review (Avg 4 weeks) P&T Committee Agenda & Review (Avg 5 weeks) Formulary Timing Factors • Representative access & interactions with physicians • Formalization of hospital committees • Lack of summer meetings Hospital Training Process (Avg 4 weeks) Rejected for formulary Trial Period – Formulary/Nonformulary Non-formulary available Forms committee (paper & electronic) (Avg 4 weeks) Product X available Variable steps Added to formulary (open or restricted) Executive Committee Review (Avg 4 weeks)

Segmentation Developing a “Segmentation Process” should be a priority of any global marketing excellence plan. Segmentation provides a microscopic look at your customers and drives them from a personality and behavior standpoint.

Initial Segmentation • Identification of appropriate surgical types • Patient type segmentation • Institutional segmentation based on IV opioid use – Led to product positioning – Sales force deployment – Target audience identification – Forecast development Need further segmentation to allow maximization of sales force direction and marketing spends

Segmentation Deliverables • Quantify growth opportunities and leverage points • Identify richest targets – Identify physician characteristics that may explain likelihood to identify need and advocate for Product X access – Identify physician characteristics that may explain Product X early adoption – Identify hospital characteristics that may explain likelihood of Product X access and usage • Ability to maximize marketing investment by segment – Invest in “richest targets” – Allocations based on launch timing – Institutional targeting plan at a hospital & physician level

Segmentation “Where to Play” Which customer segments do we want to target?

Process for Creating Segmentation Frame Physician Characteristics 1. Choose the most meaningful and actionable segmentation variables to put on the axes Hospital Characteristics 2. Combine variables on each axis in a way2. Put variables that will further explain differences in behavior(s) 3. Identify, characterize and prioritize the segments within the frame

Segmentation Variable Prioritization Initial Set of Variables Physician Variables l Specialty l MSP Behavioral Sgmts l Target Procedure Decile (from HMS) l Target Procedure SelfReported Volume l Total Target Procedure Volume l Physician Age l Position in Hospital l P&T Membership l PMC Membership l PMT Membership l Tenure l Fentanyl Use l Practice Setting l Basal use with IV PCA l Negative PCA Experience Patient Variables l % Poor Venous Access l % Elderly Patients l % Frail Patients l % Morbidly Obese Pts Hospital Variables l MSA Population l Population Density l Hospital Bed Size l Existence of Rehabilitation Center l # In-patient Surgical Procedures l # Surgical IC Beds l Participation in Healthcare System l Ownership Type l COTH Membership l Geography l Level of Competition l Pain Mgmt Program l Existence of PMC in Hospital l Pain Team in Hospital l Inclusion of Pain in Patient Satisfaction Survey l P&T Committee Size l Residency Program in Target Specialties Variables Used in Segmentation Frame Evaluation Criteria l Meaningfulness Testing* – Differences between values generated by cuts in variables – Statistical significance of differences – Review of population distribution generated by cuts in variables l Actionability Examination – Available in HMS or AHA databases (higher) vs. further investigation or guess work on the part of the sales rep (lower) l Hypothesizing and assessing correlation between variables Physician Variables l Specialty l Physician Age l Position in Hosp – P&T Membership – PMC Membership – PMT Membership Hospital Variables l HSA Population l HSA Population Density l Ownership Type (Nonprofit, for-profit, govt.)

Physician Higher Procedure Volume Surgeons (incl. Gen Surg, Ortho, OB/GYN) Anesthesiologists Quantified Action Segmentation® Not Pain Mgmt Team, Committee, P&T or Chief of Service Hospital HSA Population Less than 100,000 15% phys (124) 31% launch 54% 6 months 32% ID need 22% advocate Pop Dens <1500 ppl/mi2 HSA Population 100,000 or more 24% phys (230) 36% launch 54% 6 months 27% ID need 21% advocate Pop Dens 1500+ ppl/mi2 10% phys (87) 32% launch 50% 6 months 16% ID need 12% advocate Notforprofit V Pain Mgmt Team, Committee, P&T or Chief of Service Age <50 13% phys (117) 35% launch 53% 6 months 46% ID need 42% advocate Age 50 and over III Not Pain Mgmt Team, Committee, or P&T Member II Pain Mgmt Team, Committee, or P&T Member I IVa IV 34% phys (317) 34% launch 53% 6 months 24% ID need 19% advocate 13% phys (45) 36% launch 50% 6 months 41% ID need 28% advocate 15% phys (52) 34% launch 47% 6 months 52% ID need 42% advocate IVb 11% phys (91) VI 24% launch Other (for profit 42% 6 months and govt.) Note: Target procedures = avg. target procedures per physician in cell.need avg. days of therapy for physicians in cell. 24% ID DOT = Source: Weighted data from IONSYS 2005 Quantitative Segmentation Study, N = 748, AHA data not available for all physicians. 17% advocate Hospital data missing for 3 anesthesiologists, 1 OB/GYN, and 1 general surgeon.

Overview: Key Insights • Specialty (surgeon vs. anesthesiologist), the role of the physician in a hospital and hospital context (surrounding population and ownership type) all have a meaningful impact on physician attitudes and behaviors toward Product X • Anesthesiologists play a central role for product access and usage as pain and fentanyl experts sitting on influential pain management and P&T committees and participating in 4-5 times as many procedures as surgeons • Product X is expected to take significant share across all target procedures from multiple pain alternatives, but particularly IV PCA (50-55% share at 6 months post-launch in target segments) • ~ 80% of P&T members expect Product X formulary approval to be likely, if economically comparable to IV PCA. Only 1% of P&T members expect formulary approval to be very unlikely.

Understanding the “Why” Behind Product X Segmentation Potential surgeon targets for product usage Questions Explored l What makes physicians more likely to become product advocates for Product X? Physician – Specifically, what are the drivers for Segment I and III? l What makes physicians likely to become high users of Product X at launch? Higher Procedure Volume Surgeons (incl. Gen Surg, Ortho, OB/GYN) Not Pain Mgmt Team, Committee, P&T or Chief of Service Hospital l What accounts for the differences in product advocacy / usage between older and younger surgeons in Segments IV, V, and VI? What other hospital attributes help explain why population density is a meaningful cut of Segment IV? Pain Mgmt Team, Committee, P&T or Chief of Service Age <50 – Specifically, what are the drivers for Segments IV, V and VI? l HSA Population Less than 100,000 Pop Dens Not <1500 - ppl/mi2 HSA Populati forPop pro on Dens 100,000 fit 1500+ or more ppl/mi2 Other (for profit and govt.) Primary targets for product advocacy IV (IVA + IVB) IVb VI Not Pain Mgmt Team, Committee, or P&T Member Pain Mgmt Team, Committee, or P&T Member III V IVa Age 50 and over Anesthesiologists II I

Conclusions • Original segmentation assumptions validated by quantitative study – Membership on P&T, Pain Committee, etc. – Role of key stakeholders • Little difference in Product X share by surgical specialty; practice setting drives usage patterns • Strong correlation with access targets and high product usage • Attitudinal insights will help influence messaging • Pre-launch account planning essential for rapid uptake

“Value Proposition” Every Global Marketing Excellence plan where a product is featured should have a “Value Proposition” structure. Detailed in the next few slides provide examples of how the building of a “Value Proposition” statement/structure is built.

Product X Value Proposition Product X Patient & Nurse Satisfaction Patient & HCP Safety IV PCA Resources Utilization


Product X Global Positioning Who: (target audience) For all healthcare professionals For: (patient types) …..whose patients have acute post op pain and require strong opioids, (competitive framework) patient-controlled Product X is a form of parenteral analgesia which (customer benefit – emotional/end use/functional benefits) is needle-free so it makes my life easier because it is comfortable, safe and easy to use, providing optimal pain relief (reasons to believe –product attributes)

Product X Benefit Ladder Benefit Ladder Emotional benefits End-use benefits Functional benefits It makes my life easier End-use benefits: Anesthesiologist/Surgeon Quick,safe pain relief New tool in my armamentarium Mobility signals recovery     Comfortable Easy to use, new option Safer Mobility Product benefits  Therapeutic equivalence to IV PCA morphine  Similar s/e to IV PCA  Compact, needle free, pre-programmed system  Innovative, single use, off the shelf, disposable system

Product X S.W.O.T Analysis Building a SWOT analysis as part of your global marketing excellence plan can help you identify where your product can and should receive that best chances to be successful. Being honest and forthcoming with your SWOT analysis can prepare you for any market dynamic.

Strengths • • • • • • • • • Unique technology Pre-programmed Minimizes risk of medication errors Extensive Health Outcomes platform Easy to administer Enhances mobility Non-invasive technology Efficacy equivalent to IV PCA morphine Effective in a broad range of surgical procedures and patient types • High degree of brand acceptance • Large volume of quality clinical data • Increased nurse and patient satisfaction

Weaknesses • • • • • • Perception that one size does not fit all Inability to precisely query the system Inability to titrate or adjust dosing Lack of supplemental dosing recommendations No onset of action data Challenges to successful implementation of Risk Management Plan (returns & disposal processes) • Lack of a bolus dosing feature • Lack of reliability in technical/manufacturing process • Potential of uncovered accounts in HSA <100k

Opportunities • Exploit heightened focus on patient safety • Raise noise level on the limitations of current modalities (IV PCA & IM) • Exploit the growing awareness of safety concerns with IV PCA • Minimize analgesic gaps through greater continuity of care • Capitalize on the current nursing shortage • Exploit the fact that our competitors have a low share of mind among our target audience • Fully prepare the marketplace due to expected time to launch

Threats • • • • • • • • Lengthy formulary review process Lack of P&T meetings during summer months (June launch) Cost perception may be difficult to overcome High degree of satisfaction with IV PCA HCP experience level is low with using fentanyl in APOPM Potential for an aggressive competitive response Difficulty in accessing customer due to OR setting Limited perception of transdermal (patch) technology

Critical Success Factors • Establish stronger company presence with key stakeholders pre-launch • Develop and implement Marketing Mix to strategically target key HCPs • Gain awareness and acceptance of Product X value proposition • Accelerate time to formulary approval • Insure appropriate product procurement and usage

Strategic Priorities Establishing the Strategic Priorities of your global marketing excellence plan is probably the most important part of your plan because establishes “goal focus”, “financial focus”, and “Lean Thinking”.

Product X Strategic Priorities • Disrupt perceived market satisfaction • Establish leadership presence with target audience • Exploit uniqueness of the product • Gain rapid availability and generate positive initial product experience • Optimize communication of Product X value proposition

Strategic Priorities • Review brand strategic plan • Gain buy-in on – Tactical direction – Allocation of funds • • • • Investment by strategy Distribution of funds by broad bucket Pre-launch and Post-launch spends Spend by key tactic – Highlight continuing spends from prior year

Critical Success Factors • Establish stronger company presence with key stakeholders pre-launch • Develop and implement Marketing Mix to strategically target key HCPs • Gain awareness and acceptance of Product X value proposition • Accelerate time to formulary approval • Insure appropriate product procurement and usage

Product X Strategic Priorities • Disrupt perceived market satisfaction • Establish leadership presence with target audience • Exploit uniqueness of the product • Gain rapid availability and generate positive initial product experience • Optimize communication of Product X value proposition

Product X BMEs A d v er t is in g $ H C P Ed u c a t io n $ Sea r c h Pr o g r a m $ Spea k er Tr a in in g a n d Pr o g r a ms $ M a r k et in g Res ea r c h $ Pr o mo t io n a l M a t er ia l s $ Sa mpl es $ Pu b l ic a t io n Pl a n $ C o n v en t io n s a n d Ex h ib it s $ In t er n et $ Pu b l ic Rel a t io n s $ Sel l in g A id s $ In c en t iv e Pl a n $ St r a t eg ic C u s t o mer M a r k et in g $ Jo u r n a l A d v er t is in g $ TOTA L $ 2 ,0 0 0 1 ,1 6 0 500 4 ,3 7 5 1 ,2 0 0 5 ,2 5 0 5 ,3 0 0 370 2 ,2 0 0 600 870 6 ,3 3 5 1 ,5 0 0 440 2 ,5 0 0 3 4 ,6 0 0

Spend by Strategic Priorities Gain Rapid Availability and Generate Positive Initial Product Experience 34% Optimize Communication of Value Proposition Disrupt Perceived Market 2% Satisfaction 14% Establish Leadership Presence With Target Audience 31% Exploit Uniqueness of Product 19%

Critical Success Factors • Establish stronger company presence with key stakeholders pre-launch • Develop and implement Marketing Mix to strategically target key HCPs • Gain awareness and acceptance of Product X value proposition • Accelerate time to formulary approval • Insure appropriate product procurement and usage

Forecast Forecasting your Global Marketing Excellence plan can be a challenging one because of the unpredictabilities that occur in the marketplace. A solid forecast that’s based on market statistics/dynamics and vision is vital for a product to succeed.

Forecast Architecture Step 1 – Product X Days of Therapy 7.9M Total Surgical Procedures Procedures w. Injectable Opioid Procedures w. Opioid x Product X PX Share Step 2 – Valuation x Product X Price Per Day of Therapy = Assumptions supported by US quant. study and market analogues From Solucient Data Product X Total Days of Therapy x Product X DOT / procedure = Product X Dollars Product X Days of Therapy

Product X Forecast Assumptions • Total Procedure Growth for Unique Surgical Discharge by Specialty (All Surgical Px Discharges) 2012 2013 2014 YTD 4/12 2013 2014 All Spec -5.6% -4.2% 1.5% 0.6% -0.2% -1.4% Ortho OBGYN 2.1% 3.9% 0.7% 0.2% General 1.5% 1.3% 0.9% 0.1% -1.5% -7.3% 0.8% 0.0% Urology -4.6% 1.1% -8.8% -7.3% Other 5.9% 3.3% -1.3% -3.9% • Trending historical Market Unique Discharges and applying findings from market research that overall procedures are moving to outpatient settings (Hysterectomy, Shoulder, Cholecystectomy). • Penetration of total procedures • 2012 87.3 % • 2013 86.3% • 2014 85.5% Shift to outpatient Minimally invasive

Product X Forecast Assumptions • Injectable Opioid Penetration of opioid procedures • 2012 94.9% • 2013 95.1% • 2014 95.9% • Product X Procedure share of Injectable Opioid • 2012 Overall Product X Share 1.4% Exit share = 5.4% • 2013 Overall Product X Share 11.0% Exit share = 14.7% • Shares calculated from quant study

Product X Forecast Assumptions • Days of Therapy, Units of Product X per Procedure 2013 2014 • All Specialties 2.1 2.1 • Orthopedics 2.1 2.1 • OBGYN 1.6 1.6 • General Surgery 2.8 2.8 • Urology 2.0 2.0 • Other 2.0 2.0 Results of Quant Study, looked at key procedures with in each above specialty to come up with an overall weighted Days of Therapy per Specialty. • GTN Rates • 2012 - 91% • 2013 - 91%

Product X Forecast Assumptions • Stocking and Months of Supply • Currently built into model is a 5% demand stocking call. • Current Price 2013 • GOP $116.48 $116.48 • NET 2014 $106.00 $106.00 •Pricing research under way to determine latest pricing assumptions and strategies.

Product X Forecast 2013 2014 7.886M 7.830M 1.4% 11.4% 107,796 858,466 2.1 2.1 Product X Total Units 228,800 1,822,674 GOP Price per Unit $116.48 $116.48 5% of units 5% of units 91% 91% $25.5M $202.9M Injectable Market Px Product X Share Product X Px Product X Days of Therapy Pipeline GTN Rate NET Dollars

Product X P&L Pr oj ec t ed La un c h 7 / 2 0 1 5 Pr oduc t X $ M M 's 2014 P r e L a u n c hP o s t L a u n c h N TS $ GP Se l l i n g 2015 P r e L a u n c h P o st L a u n c h $ 2 6 .0 $ $ 5 .0 - $ 1 9 .9 $ - $ - L a u n c h M eet in g / C D &T $ 3 .8 $ 2 .5 M a r k e t i n g (B M E / M k t R e s e a r c1 0 .0 $ h) $ - $ 1 6 .9 $ 1 1 .4 C l in ic a l 7 .7 $ - $ 7 .3 $ - 2 .4 $ - $ 4 .0 $ 7 .6 OI& E $ - $ - C a r r yin g C o st $ - $ 0 .4 $ Ot h e r (d i s t , n e t a d mi n , l e g$ l ) a IBT $ (25.1) $ - $ (32.0) $ (2.0) Taxes $ (8.8) $ - $ (11.2) $ (0.7) MNI $ (16.3) $ - $ (20.8) $ (1.3)

This slide presentation is for illustration purposes only and to show how AH2 & Beyond Consulting can help you build your Global Marketing Excellence Strategy Plan All content & data is fictitious and is only for illustration purposes

Contact Us Checkout my “Global Sales-Marketing Business Plan” for the Pharma/Med Device Industry featuring Pain Management. You can also checkout my background/work by clicking on the following links:

Contact Us Andre’ Harrell AH2 & Beyond Consulting 267-221-8529

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